MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068505001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adult Respiratory Distress Syndrome (1696); Calcium Deposits/Calcification (1758); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Nerve Damage (1979); Pain (1994); Rash (2033); Scar Tissue (2060); Burning Sensation (2146); Ulcer (2274); Urinary Frequency (2275); Anxiety (2328); Prolapse (2475); Weight Changes (2607); Fluid Discharge (2686); Constipation (3274); Movement Disorder (4412); Cough (4457); Dyspareunia (4505); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the mesh removal surgery.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6) 2008.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on (b)(6) 2018.

Manufacturer Narrative

Correction: block b3 date of event: the exact event onset date is unknown.The provided event date of january 8, 2018 was chosen as a best estimate based on the date of the mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f1903 captures the reportable event of mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6) 2008.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on january 8, 2018.Additional information received on august 8, 2022- it was reported to boston scientific corporation that obtryx system - halo device was implanted into the patient during a transobturator suburethral sling procedure performed on (b)(6) 2008 for the treatment of cystocele and stress urinary incontinence.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on january 8, 2018.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6) 2008.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on (b)(6) 2018.Additional information received on october 11, 2022: the patient was seen and examined on (b)(6) 2017 for bladder leakage.The patient has had bladder mesh placed in 2008.Has leakage with coughing and sneezing.The patient presented with an overactive bladder.The overactive bladder was described as voiding 12 times per day, wetting clothes frequently and wearing pads.The severity of the overactive bladder was severe.The overactive bladder was worsening.The overactive bladder has lasted for 3 month(s) and worse, which actually began a year ago.Associated symptoms consisted of bladder dysfunction.The patient has had a hysterectomy and the last menstrual period was not applicable.Last menstrual period secondary to endometriosis.She presented today for evaluation.The physician discussed the kinds of incontinence of urine including overactive bladder and overflow incontinence which could all manifest in this way.She was made aware the approaches to these problems might be different and so they need to evaluate with a urodynamic study.She will be scheduled appropriately.On (b)(6) 2017, the patient called and stated to the nurse on the phone she had went to the uw to see a specialist for her abnormal bleeding and to discuss a vaginal mesh that was faulty.She stated she did not want to see her previous physician as they did not believe her concerns and said she found her symptoms on the internet.The patient stated she wanted to see another physician who can remove the faulty mesh and help her with the bleeding she has.Appointment was set up for thursday, (b)(6) 2017.The patient was seen and examined in the emergency room on (b)(6) 2017 for lower abdominal pain for four hours.The patient stated the pain was 10/10 at this time.The patient stated pain was from her bladder mesh sling eroding into stomach.The patient stated pcp sent her here for evaluation.The patient also stated rectal bleeding.In the physician's assessment, the patient had chronic pelvic pain.She was prescribed with norco 5 mg-325 mg oral tablet (prescribe): 1 tab(s), oral, every 6 hours (interval), as needed for pain, 15 tab(s), 0 refill(s).Patient was given the educational materials for pelvic pain.A follow up with the physician as needed and to call for follow up appointment.On (b)(6) 2018, the patient underwent an excision of transobturator mesh sling and cystourethroscopy.Her pre- and post-operative diagnosis was pelvic pain, groin pain, abdominal pain, and history of prior transobturator sling placement.The patient had a history of tobacco use and chronic pain.She was evaluated and found to have tenderness with palpation of her sling that recreated some of her groin pain.She understands that her incontinence may be affected and this may or may not alleviate her pain symptoms.After risks and alternatives were discussed with patient, she agreed to proceed with the above procedure.Procedure findings include the urethral vaginal portions of her mesh sling were removed in entirety and aggressively into the obturator foramen via the transvaginal approach.Cystourethroscopy was within normal limits without any acute findings.During the procedure, the patient was correctly identified by name and date of birth and brought to the operating room.General anesthesia was induced, and she was positioned in dorsal lithotomy position, prepped and draped in standard sterile fashion.Appropriate antibiotics were administered.A virginia mason surgical pause was conducted.They started the procedure by getting vaginal exposure with a lone star retractor, blue hooks, and a foley catheter was left to gravity drainage.The physician could palpate a band-like structure consistent with a mesh sling.The physician made two lateral oblique incisions in the periurethral area and extended these laterally.They could palpate the sling with the tips of their metzenbaum scissors.The physician then dissected it between the two lateral oblique incisions under the urethra and converted this to an inverted u incision.The physician made an anterior vaginal wall flap.The physician could visualize the mesh sling.The physician dissected it out.It was quite adherent.The physician made an incision in the mesh sling in the right lateral periurethral area.The physician dissected out the patient's left arm of the sling aggressively into the obturator foramen.It was quite inflamed in the groin area.The physician carefully dissected the mesh sling away from her urethral vaginal tissues.The physician went approximately one centimeter beyond the foramen and isolated the mesh away from her tissues and then excised it and truncated it with the curved mayo scissors.The physician sent this off as a specimen; it was approximately five centimeter in length.The physician went back to the right arm of the sling, and they dissected it away from the tissues, away from the urethra and the vagina.It was also adherent and inflamed.The physician brought this out to the groin on her right side and dissected it free from the obturator foramen, approximately one centimeter beyond, and excised it.This was approximately 2.5 cm in length for a total length of 7-8 cm of mesh removed.They irrigated the wound.Hemostasis was excellent.We then reapproximated the periurethral fascia of the urethra where the groove where the sling was.This was done with several interrupted #3-0 vicryl sutures.The physician then performed cystourethroscopy, which revealed no acute findings of the urethra or bladder, normal bilateral urinary orifices.The physician then advanced the anterior vaginal wall flap and closed in a running interrupted fashion with #2-0 vicryl.A final foley catheter closed system was placed.Vaginal packing with premarin cream was also placed in the vagina.The patient was awoken from general anesthesia and transferred to her room in excellent condition.There were no complications at the end of the procedure.On (b)(6) 2018, the patient was seen and examined that day for itchy open sores on her skin since (b)(6) 2017.It started on her right thigh, now spreading throughout her body to mid/lower back, and right cheek.The patient had a history of chronic infection.The mesh removed two weeks prior.Itching, skin problems, fatigue, pain, gastrointestinal upset all much improved since then.The patient had a history of autoimmune problem, initially thought to be systemic lupus erythematosus, which was later diagnosed as mixed connective tissue disease.No history of skin disease like this in past, and the patient asked if it was related.Etiology and chronic irritation of prurigo nodularis was reviewed from friction, rubbing or trauma.It was also reviewed not touching the area as able.Treatment options were reviewed including to watch for occlusive patch, intralesional triamcinolone and shave removal.The patient elects to try watchful, waiting and minimizing trauma for now.After risks, benefits, and alternatives reviewed and consent, intralesional triacinolone acetonide 10 mg/ml x 0.5 ml injected via 30-guage needle into the five inflamed papules.As for the patient's mixed connective tissue disease, there were no evidence of cutaneous findings.Reassurance was given that there was no evidence of progression of her disease.Recommended routine physicals and further screening based on symptoms and to return to the clinic as needed.The patient was seen and examined on (b)(6) 2018 for a follow up after surgery to help with mesh removal in the pelvis.She has chronic pain due to mesh placement to help with urinary incontinence years ago.She has been working with the surgeon up in seattle and they removed most of the mesh on (b)(6) 2018.She stated that her pain was significantly improved.She was not taking any opiates at this time.Her primary reason for presenting today was because she was upset about a phone call that she received from our office within the last couple weeks.They had given her norco no.30 for her continued pelvic pain.On the same day, they did a urinalysis to make sure it would be used properly and safely.Utox revealed she was positive both for breakdown products of norco and alcohol.She was then contacted and reminded that the combination of these two medicines were exceptionally dangerous and that if they saw this again, they would no longer be able to give her opiates for pain.The primary reason for calling was for her education due to concerns for her safety.They already discussed with her at the prior visit were not going to fill her opiates long-term without either her current surgeon working on her pelvic pain with her or a pain specialist stating that it was appropriate.She felt offended by the phone call.She repeatedly stated that they just think she was a drug seeker.She did have a history of pain management with opiates and voluntarily quit that.She stated that the norco they gave her wasn't really strong enough to touch her pain anyway and that her pain was a 12-13 out of 10 though she stated that she sure everybody said that.She did not request opiates today.She was using tylenol for pain relief.Suggested to her that this has been a misunderstanding.She accepted that.They will refill her acetaminophen today and instructed to take 1-2 tabs orally every four hours as needed for pain and not to exceed 4000 mg/day, #360 tab(s), 11 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up from emergency room for a face infection she has been treated and it has gotten better but not completely gone.The patient had a long history of skin problems who was seen and examined on (b)(6) 2018 to follow-up on recent treatment of cellulitis of the right face.The cellulitis appeared to have started with a prurigo nodule as diagnosed.Unfortunately, the nodule eventually resulted in an infection.The infection spread to cover much of her face.She was treated with bactrim and bactroban initially but without much improvement.Two days later when she was back in the emergency room, augmentin was added.The augmentin began to decrease the inflammation and erythema and treat the infection.She had slow improvement over the course of the next approximately two weeks.At that point, she felt like it might be getting worse so she came back into the walk-in clinic.The physician gave her a single dose of im ceftriaxone and attempted to culture the wound.The wound culture thus far showed 2+ coagulase negative staph.Since that time, she felt like the erythema has completely dissipated reversing the course of the couple days prior to the ceftriaxone.She reported today but the physician cannot confirm if that the nodule on her cheek was treated with steroids shortly before all this happened.Remained unclear why she was having these nodules.She did have surgery planned to remove what was remaining of the mesh.Upon examination, there was a tiny 0.1 cm ulceration in her right cheek with a little bit of erythema around that approximately 1 cm though the erythema was not warm and certainly not bright.This was almost the same color as her surrounding skin.The physician tried to express anything from the wound but nothing was able to come out.She did have some tenderness with this.At this time, it looked like the cellulitis was probably adequately resolved.The physician did not think further antibiotics was needed.She should continue hibiclens treatment once a week to help prevent recurrent infections due to her nodules.Discontinue out when dermatology the dove fills appropriate.Hopefully, these nodules will cease or at least slow down significantly after she has remainder of the mesh removed from her body.The patient was seen and examined on (b)(6) 2018 for a follow up for lesions on face, chest and knee.This has been an ongoing problem for her, for which she saw a specialist in seattle.The problem seemed to stem from prurigo nodules, which become infected.Last month, she was treated with oral antibiotics for infection in these lesions, however this was not completely effective so she presented to clinic and received an injection of 1 gm rocefin, which she stated completely reversed the infection.Over the past week, she was again experiencing swelling, redness, and pain in the right cheek.She did note discharge of yellow fluid from the wounds.She will also have a follow up with her skin specialist a week later.At the (b)(6) 2018 visit, she was also assessed for severe exacerbation of left knee pain.She was to be given with im rocephin 1 gm that day for cellulitis which the patient tolerated well with no complications.Follow up with specialist in seattle next week.May continue topical therapy and was sent prescription for keflex.Follow up if not improving.Prescription was given for cephalexin, (500 mg) 1 cap(s), oral, every eight hour (interval), for 5 day(s), #15 cap(s), 0 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up ongoing infection.Discussed stronger antibiotic for face.Since her last visit she did see her specialist in seattle (surgeon, not dermatologist), who advised rather invasive surgery from how patient described, though at this time the physician did not have documents from specialist to reference.There was thought that the source of recurrent infection was retained mesh.She last received im rocephin 2 weeks ago, and noted significant improvement in the pain, swelling, redness of the prurigo lesions.She has a follow up with a dermatologist next month.She continued hibiclens and mupirocin.She noted the facial lesions has become more painful, and she was concerned it was more infected.However, the patient had no fever or chill, and there was no drainage.Upon examination, the patient had a right facial lesion, with some darkened discoloration and sunken appearance next to slightly red raised nodule with shallow ulcer.No surrounding erythema.No discharge.No streaking redness.Nontender.No other lesions noted.In the physician's assessment, he was not convinced that further antibiotic was totally necessary at this point.She may continue the hibiclens and the mupirocin.She has a follow up with a dermatologist next month.If things were getting worse in the meantime, the patient could consider another course of oral antibiotics or another rocephin injection if needed.The patient was seen and examined on (b)(6) 2018 for a follow up of prurigo nodules on trunk, legs, and face.Last visit was on (b)(6) 2018 with the physician for same.The patient had intralesional triamcinolone at that time.Since last visit, has a new diagnosis of infected mesh in her body and was scheduled for surgery next month.The patient has been on extensive antibiotics, most recently keflex, with good response to cheek bumps.Bumps on trunk, leg resolved; those on right cheek, especially one nodule, persisted with pain and itching.Her gyne team recommended no further intralesional triamcinolone until mesh problem was addressed.Upon examination, the patient had a one-centimeter subcutaneous nodule on the right cheek with overlying angulated erosion.The remainder of skin areas examined were unremarkable.The following impression and plan were provided by the physician which included injection of intralesional up to and include seven lesions likely cyst versus furuncle versus staph, though multiple bacterial culture negative keflex appeared to be helping, continue with this treatment.Continue with hibiclens weekly.For acute control of pain and itching, intralesional lidocaine 2% x 1 ml injected into right cheek nodule.Return to clinic in 8 weeks after upcoming surgery or as needed.The patient was seen and examined on (b)(6) 2018 for a follow up on chronic skin infection.She was last placed on keflex for her ongoing facial cellulitis and prurigo lesion.She was in consultation with the surgeon in seattle to remove the mesh from the pelvis which they believe may be causing some ongoing infections.She was also seen by a dermatologist in seattle who she states has recommended she continue the keflex until she underwent surgery.At this point, the physician had no notes from these providers.She stated that after finishing the antibiotics, a few days later she developed severe swelling and redness of the face, node swelling, fevers, chills, fatigue, new skin lesions which were draining green material.She presented to the emergency room and was given iv antibiotics, and was advised to continue the keflex.At this point, she noted no further drainage, no new lesions, no further fevers or chills.Upon examination, it was noted that the patient had a chronic lesion on the right cheek.A small erythematous papule with excoriation but no discharge central chest.Assessment and plan of the physician included a refill of her antibiotic, and was advised that she follow-up with her dermatologist to consider appropriate chronic care.Follow-up with the surgeon for removal of the mesh.Orders include cephalexin, (500 mg) 1 cap(s), oral, every 12 hour (interval) for 14 day(s), #28 cap(s), 0 refill(s).Medication side effects were addressed, and the patient was agreeable to the above plan.All questions were addressed during the visit.The patient was seen and examined on (b)(6) 2018 for prurigo nodularis with excoriations and secondary infections, last visit with the physician was two months prior.Since the last visit she was taken off the antibiotics a week ago and then she worsened.Her temperature was over 99-degress fahrenheit.She noted new lesions on her thigh.She was becoming "sicker by the day".No surgeries at this time.Time.She noted that the mesh inside her was infected.She noted the antibiotics was working and the lesions were resolving.She noted the lesions were painful.She was now allergic to cortisone.She took antibiotics (cephalexin) twice a day and would like to restart.Upon examination, fullness on the right neck lymph was noted versus abscess.Her right anterior thigh was noted to have an angulated erosion.Recommendations for the patient's assessment and plan included the following: for prurigo nodularis (right thigh), unfortunately her lesions were worsening.Differential diagnosis including increased picking and secondary infection.She reported that she was also allergic to cortisone and will develop flu-like symptoms upon use, so the physician will stop ilk injections at this time.Patient was concerned for possible infection.She noted that she was worsening.She will be restarted on antibiotics today due to cough and fullness of the right neck.A culture was taken from her right anterior thigh to check for infectious agents and of throat, the patient was prescribed with cephalexin 500mg capsules twice a day, cephalexin 500 mg oral capsule; to take one capsule (500 mg) by mouth two times a day and dispensed 60 capsules with 5 refills.Skin culture and sensitivity test with gram was advised and patient agreed with the evaluation with identification in future to consider staph eradication protocol.The patient could do well with bleach baths and was reviewed today.For lymphadenopathy of right cervical region, the patient reported that she was worsening and on exam has shown cough and increased fullness of the right neck.Patient was going to follow up with infectious disease specialist who will assess her.Culture was ordered and swabbed from throat.The patient was expected to return to clinic in four weeks or sooner as needed for acute concerns.The patient presented to the emergency department complaining of suprapubic and right lower quadrant abdominal pain along with bright red blood per rectum.Two years ago, she had intermittent rectal bleeding.Eventually, it was determined to be related to a vaginal mesh that had been placed, so in january of this year she had the mesh removed.She reported that they were unable to remove the entirety of the mesh because some of it was embedded into tissue close to some nerves.Following the surgery, she developed some sort of infection, so a planned procedure to remove the rest of the mesh was canceled and rescheduled for november of this year.For the past two days, she has had some suprapubic and right lower quadrant abdominal pain.This morning she noticed that she was again passing blood with her stools.She also noted more blood this evening and decided it was prudent to come to the emergency department for evaluation.The patient described her abdominal pain was a combination of sharp and crampy.She reported that she was in pain approximately 50% of the time.The episodes of pain last to three minutes and then go away for 2-3 minutes.She can both exacerbate or bring on the pain by palpating her right lower quadrant and suprapubic area.Patient denied any vaginal bleeding.She denied any dysuria, urgency, frequency, or other gastro urinary complaints.The patient has not had fevers.She reported that she has been on multiple antibiotics continuously since her surgery in january.Currently, she was taking cephalexin.Abdominal ct findings include the lung bases and visualized mediastinum the mild atelectasis at the lung bases.No pleural or pericardial effusion.The heart size was normal.There were tiny hypodensities in the liver, as before and likely cysts.No new hepatic abnormality.The hepatic size and enhancement were normal.The gallbladder has been removed.No bile duct dilatation or bile duct stone.The splenic size and enhancement were normal.No focal splenic abnormality.There was no focal pancreas abnormality or pancreatic duct dilatation.The adrenal glands were normal.There were no calcifications in the kidneys or in the ureters.No hydronephrosis or hydroureter.No renal cortical abnormality.The enhancement of the kidneys was normal.There was vascular calcification but no abdominal aortic or iliac artery aneurysm.No retroperitoneal lymphadenopathy.There was moderate feces in the colon.Fluid was noted in the small bowel loops but no bowel dilatation to suggest obstruction.No evidence of free intraperitoneal gas.The appendix was not visualized.There was no pericecal inflammation.No evidence of mesenteric lymphadenopathy.Pelvis ct findings include the uterus has been removed.No adnexal mass, pelvic free fluid or fluid collection.No pelvic or inguinal lymphadenopathy.No focal bladder abnormality or bladder calculus.There are surgical clips in the right groin from hernia repair.No abdominal wall or inguinal hernia.Impressions include fluid in small bowel loops but no bowel obstruction or free air.The patient was constipated.The appendix was not visualized but no secondary features to indicate appendicitis.No renal, ureteral or bladder calculus.Additional findings include cholecystectomy, hysterectomy, atherosclerosis and a stable tiny hypodensities in the liver likely cysts.In the physician's assessment, the patient had hematochezia.The patient was stable and was discharged.Prescription was provided which included bentyl 20 mg oral tablet (prescribe): 20 mg, 1 tab(s), oral, every six hour (interval), as needed for abdominal pain, 24 tab(s), 0 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up for rectal bleeding.Discussed lesions and would like a drug screen.She has had prurigo nodules on face, chest which have intermittently become infected with oozing green material, swelling, redness.She has been on and off with oral antibiotics for much of this year.At her last visit the physician advised no further antibiotics until seen by infectious disease specialist, but she stated that her gyne surgeon in seattle did place her back on keflex until she could see the specialist.She did state that this improved the lesions.Since last visit she had knee scope and was doing very well.No adverse problems were noted.Great improvement in pain and mobility.The patient had 6 week follow up with surgeon yesterday.She was seen at the emergency room last night for hematochezia and pelvic pain.Laboratory results were normal, ct of the abdomen showed constipation but no acute findings.She describes brbpr, but no rectal pain or itching.She denied melena, nausea and vomiting.Her chronic pelvic pain was noted ever since a mesh in pelvis became infected and resulted in scar tissue.She stated the pain and bleeding completely resolved with use of bentyl.She did note bowel movement changes ever since she started post operative pain medications.Regarding the chronic pelvic pain, she discussed pain management with her surgeon, but she did not want to go back on opioids and was given a nerve pain medication but did not take it.She wanted to seek medical clearance for cbd/ marijuana.The patient also requested drug testing.She did have past history of cocaine use, and current marijuana use.She was on post operation pain medication.Stated she has been accused by multiple medical facilities and others of illicit drug use and wants to get verified proof that this was incorrect.The patient was due for lipids, hep c test.The patient's assessment and plan included the following: for the irritable bowel syndrome, work up was negative, stated all symptoms resolved.Likely this was secondary to constipation from recent pain medications, could be internal hemorrhoid.Declined examination today as she was doing better.Will check stool tests given ongoing stool changes, pain, and recent exposures.Advised to continue the bentyl as needed.Advised to increase fiber or use over-the-counter miralax for constipation and to increase fluids.For the skin lesion, a follow up with dermatologist and id was advised with no appearance of infection today.For fibromyalgia, discussed options.She did not want to seek medication for her chronic pain and pelvic pain.She wanted clearance for medical marijuana, but the physician cannot do this.She will seek opinion in olympia.The patient was seen and examined on (b)(6) 2018 for a follow-up on her pelvic pain, urinary incontinence and rectal bleeding.She underwent (total abdominal hysterectomy) tah for endometriosis in 2008.Six months later in 2008, she then had what sounds like tot sling for urinary incontinence with mesh.The patient stated that her problems started after that surgery.She then had sling mesh removal in (b)(6) 2018.She has felt much improved since that surgery but needed to have a urethral reconstruction.She was awaiting for that surgery.She has urinary incontinence and has to wear depends daily.Last pap smear was on (b)(6) 2017 with negative/negative.Mammogram was (b)(6) 2018, negative.Denied breast complaints.Assessment and plan of the physician included a well woman examination without gynecological examination.No pap smear needed until (b)(6) 2022.Normal breast examination.Needed screening mammogram in february 2019.Urgency incontinence will follow-up at another healthcare facility.Pelvic and perineal pain.Rectal bleeding and was advised to see her gi specialist on (b)(6) 2018.The patient was seen and examined on (b)(6) 2018 for continuing management of prurigo nodularis - excoriated papules and occasionally draining ulcers- on right cheek, right chest, and previous on back, thighs.In the physician's assessment, the question of sweets or another neutrophilic dermatosis.While not present at their appointments, her interim severe swelling could be consistent.Recommend biopsy of new area of rash for definitive diagnosis but she was hesitant, would like to defer today.Reviewed that diagnosis was important (rec biopsy) then treatment options could include oral dapsone, oral colchicine, and other oral immunosuppressants.Scheduled for three upcoming surgeries in the next six weeks, would not recommend starting immunosuppressants until after these procedures.They discussed about prescribing her sulfadiazine and dapsone creams.Risks, benefits, and alternatives reviewed today.Advised to not pick on the lesions on her right cheek.Initiated sulfadiazine 1% cream to open skin two times a day.Ordered today.Initiated dapsone 5% gel to boils two times a day.Ordered today.Silver sulfadiazine 1% external cream; to open skin twice daily dispense: 50 gm.Refill: 5.Dapsone 5% external gel; to boils on skin twice daily dispense: 60 gm; refill: advised for skin culture and sensitivity test with gram.As for the patient's prurigo nodularis, the patient reported boils on her back consistent with prurigo nodularis.Patient will be having surgery on october 16th.Biopsy offered, patient declined, plan at follow up in six weeks.Advised to discontinue oral cephalexln for now until after her surgery.Return to clinic in late (b)(6) 2018 or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2018 for a follow up on several issues and to get clearance for dental surgery (root canal).Since her last visit she underwent colonoscopy in seattle for rectal bleeding.She was found to have multiple internal hemorrhoids.She stated that she referred her back to her normal gastroenterologist for follow-up on this.She has also been seeing infectious disease specialist in olympia.She was started on topical dapsone and continued on chlorhexidine washes.She stated that she'll be following up with him after surgery from her slowest in seattle for removal of mesh, which has been the source of ongoing infection.She stated that she was diagnosed with sweet syndrome following multiple tests.She will be following up with specialists in the next week or two.The patient was seen and examined on (b)(6) 2018 for preoperative examination.She'll be seeing her urine gynecologist at virginia mason for removal of infected mesh and rectocele correction.History significant for sweets syndrome, seizure in response to sodium pentothal, fibromyalgia and urinary incontinence.She was currently being followed by gynecology, infectious disease and dermatology.She was currently continuing to experience lower abdominal pain and cramping.She denied any dysuria nor hematuria.She did recently underwent banding of hemorrhoids which was extremely successful.Since then hematochezia or rectal pain was noted.She has no cardiovascular history.She stopped smoking but did continue to use a vaporizer.She was able to complete all of her tasks by herself at home.Ekg in office today was normal.She was advised to get her labs done as previously requested by her surgeon.If needed, they can reorder this when necessary.Physical examination unremarkable.She has argument with her surgeon regarding stopping current medications before the surgery.She was low cardiovascular risk.Advised to avoid sodium pentathol, but otherwise no contraindications.The physician filled out her form for the surgeon.She wondered about home health, advised to discuss with surgeon first the physician was unsure with her recovery and expected limitations.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of january 8, 2018 was chosen as a best estimate based on the date of the mesh removal surgery.Block b5 continuation: the patient was seen and examined on (b)(6) 2019 for prurigo nodularis.She was last seen on (b)(6) 2018, at which time she was provided sulfadiazine 1% cream to be applied twice a day to open skin and dapsone 5% gel to boils twice a day.She was recommended to consider biopsy or other oral immunosuppressants if her skin erosions were not improving.Since the last visit, she saw an infection specialist at virginia mason who recommended that she stop her antibiotics.After a week, her face started to swell, so she restarted the medication about two days ago.She was now taking doxycycline and applying dapsone, the infection specialist also referred her to rheumatology.She had a biopsy on 2004, showing sweet's syndrome.In the physician's assessment, biopsy proven sweet's syndrome by 2004 pathology report.Possibly now rosacea, boils, or sweet's.Recommend she continue cephalexin 500 mg daily and topical dapsone.Discussed the risk of antibiotic resistance with long term antibiotic use.For further improvement, recommend she initiate dapsone 25 mg daily.Usually tolerated well but can cause suppression to the bone marrow.Risks, benefits, and alternatives reviewed.Offered injections today to calm the flare.Patient accepted.Considered tapering down on cephalexin at next visit.The patient was seen and examined in the emergency room on (b)(6) 2019 for an intolerable pain and her pcp cannot help.The patient had a history of irritable bowel syndrome, lupus, and a major abdominal surgery several months ago and presented for an oxycodone refill.Stated that she was allergic to ibuprofen, and she was taking as much tylenol as she can.She got her medications filled regularly by a physician and per edie review, last refill was a week and half ago.She was out of the medication and was having "severe" abdominal pain.Located over this site of her last surgery, no new symptoms including nausea, vomiting, changes in stool nor urination.Stated it was her chronic pain that she needed the medication refill for.Advised the patient that the physician cannot do narcotic refills.She denied any new symptoms or new pain.The patient was seen and examined on (b)(6) 2019 for continued management of prurigo nodularis.In the physician's assessment, the patient had a good response to kenalog injection, well-controlled with prednisone.Discussed that after lesions became under control, the next step was tapering dapsone.Patient was able to stop taking antibiotics since her last visit.Ilk offered today and patient accepted.Continue dapsone 25 mg daily and topical dapsone.Injection of intralesional up to and include seven lesions.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection was given.Return to clinic in six weeks for prurigo nodularis or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2019 for continued management of prurigo nodularis.In the physician's assessment, the patient had much improved with dapsone treatment.Good response to kenalog injection, well-controlled with prednisone.Discussed that after lesions become under control, the next step was tapering dapsone.Ilk offered today and patient accepted.Three spots on right cheek, right chest x 2.Continue dapsone 25 mg oral tab; take 2 tablets (50 mg) by mouth daily.Dispense: 60 tablets; refill: 2.Injection of intralesional up to and include seven lesions.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection was given.Labs ordered include cbc with differential.Comprehensive metabolic panel, and reticulocyte count.Return to clinic in eight weeks for prurigo nodularis or sooner as needed for acute concerns.The patient was seen and examined on (b)(6), 2019 for check up and would like to discuss medical problems and was told she needed to have knee surgery again.The patient had chronic pelvic pain and neurologic discomfort after a mesh implant became infected and had to be removed.She underwent several surgeries in the last year, and the physician started her on gabapentin for the pain.Overall, she felt much better.The left sided burning pain has resolved.However, she still has right sided pelvic pain.She saw a surgeon again in two weeks.She saw her dermatologist and id for sweet's disease and chronic lesions.These were being injected with steroids and treatment with dapsone.She was seeing ortho locally for chronic knee pain.She was finishing up pt and was set to see the surgeon again soon.In the physician's assessment, the patient needed to continue gabapentin and has been much improved.The patient was requesting to try something else to help with the ongoing right-side pain.Will try low dose amitriptyline.Follow up with surgeon was advised.The patient wanted to avoid chronic opiod if possible, if not controlled the patient could consider pain clinic evaluation.Amitriptyline 25 mg oral tablet, (25 mg) 1 tab(s), oral, once a day (at bedtime) was prescribed for chronic pain.Instructions for pain, #30 tab(s), 3 refill(s).The patient was seen and examined on (b)(6) 2019 for continued management of sweet's syndrome with associated prurigo nodutaris.Since the last visit, she noted that her sweet's syndrome has been flaring for about a week.She developed new lesions on her left cheek and central chest, and her existing lesions have increased in size.The lesions on her left cheek and on her right anterior thigh have been particularly painful.Her lymph nodes have been swollen during this period.She has been taking cephalexin with benefit.She denied any numbness and fatigue associated with her dapsone usage.In the physician's assessment, the patient has been experiencing a flare of her sweet's syndrome for the last week, and noted the development and worsening of lesions on her right thigh, chest, and bilateral cheeks.Upon examination, she has slight swelling around her jaw and excoriated plaques to the bilateral cheeks, right anterior thigh, and chest.Recommended she begin colchicine in addition to continuing her dapsone regimen.For acute treatment of the flare.In her condition, the patient would like to pursue intralesional kenalog injections.Ilk injections offered today and patient accepted.Ilk given was 2 ml (5 mg/ml) for a total of 10 mg.Continue dapsone 25 mg daily and topical dapsone.Colchicine 0.6 mg oral tablet; take 1 tablet (0.6 mg) by mouth two times a day.Dispense: 60 tablets; refill: 2.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection.Injection of intralesional up to and include seven lesions.The patient was advised to return to the clinic in six weeks or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2019 for sweet's syndrome and prurigo nodularis.Since the last visit, she started taking the colchicine 0.6 mg and reported that her sweet's and prurigo nodularis has improved significantly.She had random breakouts last week on her chest, left cheek, and left lip and she reported that these lesions are "flaky" off much quicker.In the physician's assessment, the prurigo nodularis and sweet's syndrome improved on dapsone 25 mg twice a day and colchicine 0.6 mg.Recommend she continue.Risks of medications were reviewed.She will let the physician know if she became fatigued or if she noticed numbness and tingling.The patient was advised to return to the clinic in eight weeks or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2019 for continued management of sweet's syndrome and prurigo nodularis.Since the last visit, she reported that she did not increase her dose of dapsone.She has noticed that the lesion on her left cheek has on gotten worse.She has also noticed a new lesion on her right cheek.She thought that these flare up more with stress.She was having surgery on her left knee this week, which was causing her to be more stressed than usual.No new treatments have been tried.Given she was having surgery this week, the physician recommend that she not change anything with her medications until afterwards.The patient was seen and examined on (b)(6) 2020 for continued management of sweet's syndrome and prurigo nodularis.Since the last visit, the lesions on her right and left cheek have returned.She has noticed that the lesion on her right cheek in particular has become harder.She has also noticed there was a lesion on her chest.She has noticed that when she was stressed it made these lesions worse.No treatments have been tried.Exacerbation factors unknown.The patient had a recent knee surgery that went well.In the physician's assessment, the patient was stable overall.The patient flared a bit with stress (e.G.Recent knee surgery).Tolerating dapsone well, no nausea nor vomiting, shortness of breath, increased fatigue at 50 mg daily.The patient presented today with a worsening lesion on her left and right cheek and her chest.She thought that the lesions flare under stress.Given that ilk has been beneficial in the past, the physician recommend that they do ilk injections today and patient accepted.The patient was advised to return to the clinic in four to six weeks or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2020 for follow up on problems due to the mesh and discuss the gabapentin she stopped due to side effects which was giving her breathing problems.Patient was also concerned about her weight loss.The patient has history of chronic pelvic neuropathic pain.She has history of a mesh was which was placed, became infected and has caused ongoing problems.She continued to follow up with her surgeon in seattle.She stated she recently had a follow-up and was advised to follow-up in the next month or two for her one-year checkup.There has been minimal improvement since the surgery.Pain was severe and daily, burning and deep in nature.She was placed on gabapentin for this which was helpful however she did not wish to take this medication anymore.She stated that it caused her respiratory distress as well as dizziness.She has stopped completely and was taking three tablets/day.She also stated that she has a seizure disorder.The physician has not witnessed seizure nor saw neurology notes confirming this.She has had no recent seizure activity.She would like to change to a different seizure medication.She recently had knee surgery with orthopedist.She stated this was healing well.She was currently on a crutch.In the physician's assessment, the patient has not had seizures while on gabapentin.The physician will titrate her off and changed to trileptal as this may help with her neuropathic pain as well.Going to place referral to a neurologist for formal seizure work-up and recommendation.The physician would also like if they could address her neuropathic pain.They did discuss pain clinic as a possibility.She was instructed to call her surgeon for her yearly follow-up.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient code e2401 captures the reportable event of unknown injury.Impact code f1903 captures the reportable event of mesh removal.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information received on october 10, 2022.Block e1: the explant surgeon is: (b)(6).Block h6: patient code e172001 captures the reportable event of abscess.Patient code e230901 captures the reportable event of calcification.Patient code e0701 captures the reportable event of respiratory distress.Patient code e2330 captures the reportable event of pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e2339 captures the reportable event of ulcer.Patient code e1906 captures the reportable event of infection.Patient code e2326 captures the reportable event of inflammation.Patient code e1710 captures the reportable event of lesion.Patient code e0122 captures the reportable event of movement disorder.Patient code e1705 captures the reportable event of burning sensation.Patient code e2312 captures the reportable event of fatigue.Patient code e230101 captures the reportable event of fever.Patient code e1715 captures the reportable event of scar tissue.Patient code e2315 captures the reportable event of fluid discharge.Patient code e0123 captures the reportable event of nerve damage.Patient codee2338 captures the reportable event of swelling.Patient code e0506 captures the reportable event of hemorrhage.Impact code f2303 captures the reportable event of medication required.Impact code f1202 captures the reportable event of disability.Impact code f1901 captures the reportable event of additional surgery.Impact code f1903 captures the reportable event of device explantation.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6) 2008.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on (b)(6) 2018.Additional information received on august 8, 2022: it was reported to boston scientific corporation that obtryx system - halo device was implanted into the patient during a transobturator suburethral sling procedure performed on (b)(6) 2008 for the treatment of cystocele and stress urinary incontinence.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on (b)(6) 2018.Additional information received on october 11, 2022: the patient was seen and examined on (b)(6) 2017 for bladder leakage.The patient has had bladder mesh placed in 2008.Has leakage with coughing and sneezing.The patient presented with an overactive bladder.The overactive bladder was described as voiding 12 times per day, wetting clothes frequently and wearing pads.The severity of the overactive bladder was severe.The overactive bladder was worsening.The overactive bladder has lasted for 3 month(s) and worse, which actually began a year ago.Associated symptoms consisted of bladder dysfunction.The patient has had a hysterectomy and the last menstrual period was not applicable.Last menstrual period secondary to endometriosis.She presented today for evaluation.The physician discussed the kinds of incontinence of urine including overactive bladder and overflow incontinence which could all manifest in this way.She was made aware the approaches to these problems might be different and so they need to evaluate with a urodynamic study.She will be scheduled appropriately.On (b)(6) 2017, the patient called and stated to the nurse on the phone she had went to the uw to see a specialist for her abnormal bleeding and to discuss a vaginal mesh that was faulty.She stated she did not want to see her previous physician as they did not believe her concerns and said she found her symptoms on the internet.The patient stated she wanted to see another physician who can remove the faulty mesh and help her with the bleeding she has.Appointment was set up for thursday, november 16, 2017.The patient was seen and examined in the emergency room on december 19, 2017 for lower abdominal pain for four hours.The patient stated the pain was 10/10 at this time.The patient stated pain was from her bladder mesh sling eroding into stomach.The patient stated pcp sent her here for evaluation.The patient also stated rectal bleeding.In the physician's assessment, the patient had chronic pelvic pain.She was prescribed with norco 5 mg-325 mg oral tablet (prescribe): 1 tab(s), oral, every 6 hours (interval), as needed for pain, 15 tab(s), 0 refill(s).Patient was given the educational materials for pelvic pain.A follow up with the physician as needed and to call for follow up appointment.On (b)(6) 2018, the patient underwent an excision of transobturator mesh sling and cystourethroscopy.Her pre- and post-operative diagnosis was pelvic pain, groin pain, abdominal pain, and history of prior transobturator sling placement.The patient had a history of tobacco use and chronic pain.She was evaluated and found to have tenderness with palpation of her sling that recreated some of her groin pain.She understands that her incontinence may be affected and this may or may not alleviate her pain symptoms.After risks and alternatives were discussed with patient, she agreed to proceed with the above procedure.Procedure findings include the urethral vaginal portions of her mesh sling were removed in entirety and aggressively into the obturator foramen via the transvaginal approach.Cystourethroscopy was within normal limits without any acute findings.During the procedure, the patient was correctly identified by name and date of birth and brought to the operating room.General anesthesia was induced, and she was positioned in dorsal lithotomy position, prepped and draped in standard sterile fashion.Appropriate antibiotics were administered.A virginia mason surgical pause was conducted.They started the procedure by getting vaginal exposure with a lone star retractor, blue hooks, and a foley catheter was left to gravity drainage.The physician could palpate a band-like structure consistent with a mesh sling.The physician made two lateral oblique incisions in the periurethral area and extended these laterally.They could palpate the sling with the tips of their metzenbaum scissors.The physician then dissected it between the two lateral oblique incisions under the urethra and converted this to an inverted u incision.The physician made an anterior vaginal wall flap.The physician could visualize the mesh sling.The physician dissected it out.It was quite adherent.The physician made an incision in the mesh sling in the right lateral periurethral area.The physician dissected out the patient's left arm of the sling aggressively into the obturator foramen.It was quite inflamed in the groin area.The physician carefully dissected the mesh sling away from her urethral vaginal tissues.The physician went approximately one centimeter beyond the foramen and isolated the mesh away from her tissues and then excised it and truncated it with the curved mayo scissors.The physician sent this off as a specimen; it was approximately five centimeter in length.The physician went back to the right arm of the sling, and they dissected it away from the tissues, away from the urethra and the vagina.It was also adherent and inflamed.The physician brought this out to the groin on her right side and dissected it free from the obturator foramen, approximately one centimeter beyond, and excised it.This was approximately 2.5 cm in length for a total length of 7-8 cm of mesh removed.They irrigated the wound.Hemostasis was excellent.We then reapproximated the periurethral fascia of the urethra where the groove where the sling was.This was done with several interrupted #3-0 vicryl sutures.The physician then performed cystourethroscopy, which revealed no acute findings of the urethra or bladder, normal bilateral urinary orifices.The physician then advanced the anterior vaginal wall flap and closed in a running interrupted fashion with #2-0 vicryl.A final foley catheter closed system was placed.Vaginal packing with premarin cream was also placed in the vagina.The patient was awoken from general anesthesia and transferred to her room in excellent condition.There were no complications at the end of the procedure.On (b)(6) 2018, the patient was seen and examined that day for itchy open sores on her skin since (b)(6) 2017.It started on her right thigh, now spreading throughout her body to mid/lower back, and right cheek.The patient had a history of chronic infection.The mesh removed two weeks prior.Itching, skin problems, fatigue, pain, gastrointestinal upset all much improved since then.The patient had a history of autoimmune problem, initially thought to be systemic lupus erythematosus, which was later diagnosed as mixed connective tissue disease.No history of skin disease like this in past, and the patient asked if it was related.Etiology and chronic irritation of prurigo nodularis was reviewed from friction, rubbing or trauma.It was also reviewed not touching the area as able.Treatment options were reviewed including to watch for occlusive patch, intralesional triamcinolone and shave removal.The patient elects to try watchful, waiting and minimizing trauma for now.After risks, benefits, and alternatives reviewed and consent, intralesional triacinolone acetonide 10 mg/ml x 0.5 ml injected via 30-guage needle into the five inflamed papules.As for the patient's mixed connective tissue disease, there were no evidence of cutaneous findings.Reassurance was given that there was no evidence of progression of her disease.Recommended routine physicals and further screening based on symptoms and to return to the clinic as needed.The patient was seen and examined on (b)(6) 2018 for a follow up after surgery to help with mesh removal in the pelvis.She has chronic pain due to mesh placement to help with urinary incontinence years ago.She has been working with the surgeon up in seattle and they removed most of the mesh on (b)(6) 2018.She stated that her pain was significantly improved.She was not taking any opiates at this time.Her primary reason for presenting today was because she was upset about a phone call that she received from our office within the last couple weeks.They had given her norco no.30 for her continued pelvic pain.On the same day, they did a urinalysis to make sure it would be used properly and safely.Utox revealed she was positive both for breakdown products of norco and alcohol.She was then contacted and reminded that the combination of these two medicines were exceptionally dangerous and that if they saw this again, they would no longer be able to give her opiates for pain.The primary reason for calling was for her education due to concerns for her safety.They already discussed with her at the prior visit were not going to fill her opiates long-term without either her current surgeon working on her pelvic pain with her or a pain specialist stating that it was appropriate.She felt offended by the phone call.She repeatedly stated that they just think she was a drug seeker.She did have a history of pain management with opiates and voluntarily quit that.She stated that the norco they gave her wasn't really strong enough to touch her pain anyway and that her pain was a 12-13 out of 10 though she stated that she sure everybody said that.She did not request opiates today.She was using tylenol for pain relief.Suggested to her that this has been a misunderstanding.She accepted that.They will refill her acetaminophen today and instructed to take 1-2 tabs orally every four hours as needed for pain and not to exceed 4000 mg/day, #360 tab(s), 11 refill(s).The patient was seen and examined on march 23, 2018 for a follow up from emergency room for a face infection she has been treated and it has gotten better but not completely gone.The patient had a long history of skin problems who was seen and examined on (b)(6) 2018 to follow-up on recent treatment of cellulitis of the right face.The cellulitis appeared to have started with a prurigo nodule as diagnosed.Unfortunately, the nodule eventually resulted in an infection.The infection spread to cover much of her face.She was treated with bactrim and bactroban initially but without much improvement.Two days later when she was back in the emergency room, augmentin was added.The augmentin began to decrease the inflammation and erythema and treat the infection.She had slow improvement over the course of the next approximately two weeks.At that point, she felt like it might be getting worse so she came back into the walk-in clinic.The physician gave her a single dose of im ceftriaxone and attempted to culture the wound.The wound culture thus far showed 2+ coagulase negative staph.Since that time, she felt like the erythema has completely dissipated reversing the course of the couple days prior to the ceftriaxone.She reported today but the physician cannot confirm if that the nodule on her cheek was treated with steroids shortly before all this happened.Remained unclear why she was having these nodules.She did have surgery planned to remove what was remaining of the mesh.Upon examination, there was a tiny 0.1 cm ulceration in her right cheek with a little bit of erythema around that approximately 1 cm though the erythema was not warm and certainly not bright.This was almost the same color as her surrounding skin.The physician tried to express anything from the wound but nothing was able to come out.She did have some tenderness with this.At this time, it looked like the cellulitis was probably adequately resolved.The physician did not think further antibiotics was needed.She should continue hibiclens treatment once a week to help prevent recurrent infections due to her nodules.Discontinue out when dermatology the dove fills appropriate.Hopefully, these nodules will cease or at least slow down significantly after she has remainder of the mesh removed from her body.The patient was seen and examined on (b)(6) 2018 for a follow up for lesions on face, chest and knee.This has been an ongoing problem for her, for which she saw a specialist in seattle.The problem seemed to stem from prurigo nodules, which become infected.Last month, she was treated with oral antibiotics for infection in these lesions, however this was not completely effective so she presented to clinic and received an injection of 1 gm rocefin, which she stated completely reversed the infection.Over the past week, she was again experiencing swelling, redness, and pain in the right cheek.She did note discharge of yellow fluid from the wounds.She will also have a follow up with her skin specialist a week later.At the (b)(6) 2018 visit, she was also assessed for severe exacerbation of left knee pain.She was to be given with im rocephin 1 gm that day for cellulitis which the patient tolerated well with no complications.Follow up with specialist in seattle next week.May continue topical therapy and was sent prescription for keflex.Follow up if not improving.Prescription was given for cephalexin, (500 mg) 1 cap(s), oral, every eight hour (interval), for 5 day(s), #15 cap(s), 0 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up ongoing infection.Discussed stronger antibiotic for face.Since her last visit she did see her specialist in seattle (surgeon, not dermatologist), who advised rather invasive surgery from how patient described, though at this time the physician did not have documents from specialist to reference.There was thought that the source of recurrent infection was retained mesh.She last received im rocephin 2 weeks ago, and noted significant improvement in the pain, swelling, redness of the prurigo lesions.She has a follow up with a dermatologist next month.She continued hibiclens and mupirocin.She noted the facial lesions has become more painful, and she was concerned it was more infected.However, the patient had no fever or chill, and there was no drainage.Upon examination, the patient had a right facial lesion, with some darkened discoloration and sunken appearance next to slightly red raised nodule with shallow ulcer.No surrounding erythema.No discharge.No streaking redness.Nontender.No other lesions noted.In the physician's assessment, he was not convinced that further antibiotic was totally necessary at this point.She may continue the hibiclens and the mupirocin.She has a follow up with a dermatologist next month.If things were getting worse in the meantime, the patient could consider another course of oral antibiotics or another rocephin injection if needed.The patient was seen and examined on (b)(6) 2018 for a follow up of prurigo nodules on trunk, legs, and face.Last visit was on (b)(6) 2018 with the physician for same.The patient had intralesional triamcinolone at that time.Since last visit, has a new diagnosis of infected mesh in her body and was scheduled for surgery next month.The patient has been on extensive antibiotics, most recently keflex, with good response to cheek bumps.Bumps on trunk, leg resolved; those on right cheek, especially one nodule, persisted with pain and itching.Her gyne team recommended no further intralesional triamcinolone until mesh problem was addressed.Upon examination, the patient had a one-centimeter subcutaneous nodule on the right cheek with overlying angulated erosion.The remainder of skin areas examined were unremarkable.The following impression and plan were provided by the physician which included injection of intralesional up to and include seven lesions likely cyst versus furuncle versus staph, though multiple bacterial culture negative keflex appeared to be helping, continue with this treatment.Continue with hibiclens weekly.For acute control of pain and itching, intralesional lidocaine 2% x 1 ml injected into right cheek nodule.Return to clinic in 8 weeks after upcoming surgery or as needed.The patient was seen and examined on (b)(6) 2018 for a follow up on chronic skin infection.She was last placed on keflex for her ongoing facial cellulitis and prurigo lesion.She was in consultation with the surgeon in seattle to remove the mesh from the pelvis which they believe may be causing some ongoing infections.She was also seen by a dermatologist in seattle who she states has recommended she continue the keflex until she underwent surgery.At this point, the physician had no notes from these providers.She stated that after finishing the antibiotics, a few days later she developed severe swelling and redness of the face, node swelling, fevers, chills, fatigue, new skin lesions which were draining green material.She presented to the emergency room and was given iv antibiotics, and was advised to continue the keflex.At this point, she noted no further drainage, no new lesions, no further fevers or chills.Upon examination, it was noted that the patient had a chronic lesion on the right cheek.A small erythematous papule with excoriation but no discharge central chest.Assessment and plan of the physician included a refill of her antibiotic, and was advised that she follow-up with her dermatologist to consider appropriate chronic care.Follow-up with the surgeon for removal of the mesh.Orders include cephalexin, (500 mg) 1 cap(s), oral, every 12 hour (interval) for 14 day(s), #28 cap(s), 0 refill(s).Medication side effects were addressed, and the patient was agreeable to the above plan.All questions were addressed during the visit.The patient was seen and examined on (b)(6) 2018 for prurigo nodularis with excoriations and secondary infections, last visit with the physician was two months prior.Since the last visit she was taken off the antibiotics a week ago and then she worsened.Her temperature was over 99-degress fahrenheit.She noted new lesions on her thigh.She was becoming "sicker by the day".No surgeries at this time.Time.She noted that the mesh inside her was infected.She noted the antibiotics was working and the lesions were resolving.She noted the lesions were painful.She was now allergic to cortisone.She took antibiotics (cephalexin) twice a day and would like to restart.Upon examination, fullness on the right neck lymph was noted versus abscess.Her right anterior thigh was noted to have an angulated erosion.Recommendations for the patient's assessment and plan included the following: for prurigo nodularis (right thigh), unfortunately her lesions were worsening.Differential diagnosis including increased picking and secondary infection.She reported that she was also allergic to cortisone and will develop flu-like symptoms upon use, so the physician will stop ilk injections at this time.Patient was concerned for possible infection.She noted that she was worsening.She will be restarted on antibiotics today due to cough and fullness of the right neck.A culture was taken from her right anterior thigh to check for infectious agents and of throat, the patient was prescribed with cephalexin 500mg capsules twice a day, cephalexin 500 mg oral capsule; to take one capsule (500 mg) by mouth two times a day and dispensed 60 capsules with 5 refills.Skin culture and sensitivity test with gram was advised and patient agreed with the evaluation with identification in future to consider staph eradication protocol.The patient could do well with bleach baths and was reviewed today.For lymphadenopathy of right cervical region, the patient reported that she was worsening and on exam has shown cough and increased fullness of the right neck.Patient was going to follow up with infectious disease specialist who will assess her.Culture was ordered and swabbed from throat.The patient was expected to return to clinic in four weeks or sooner as needed for acute concerns.The patient presented to the emergency department complaining of suprapubic and right lower quadrant abdominal pain along with bright red blood per rectum.Two years ago, she had intermittent rectal bleeding.Eventually, it was determined to be related to a vaginal mesh that had been placed, so in january of this year she had the mesh removed.She reported that they were unable to remove the entirety of the mesh because some of it was embedded into tissue close to some nerves.Following the surgery, she developed some sort of infection, so a planned procedure to remove the rest of the mesh was canceled and rescheduled for november of this year.For the past two days, she has had some suprapubic and right lower quadrant abdominal pain.This morning she noticed that she was again passing blood with her stools.She also noted more blood this evening and decided it was prudent to come to the emergency department for evaluation.The patient described her abdominal pain was a combination of sharp and crampy.She reported that she was in pain approximately 50% of the time.The episodes of pain last to three minutes and then go away for 2-3 minutes.She can both exacerbate or bring on the pain by palpating her right lower quadrant and suprapubic area.Patient denied any vaginal bleeding.She denied any dysuria, urgency, frequency, or other gastro urinary complaints.The patient has not had fevers.She reported that she has been on multiple antibiotics continuously since her surgery in january.Currently, she was taking cephalexin.Abdominal ct findings include the lung bases and visualized mediastinum the mild atelectasis at the lung bases.No pleural or pericardial effusion.The heart size was normal.There were tiny hypodensities in the liver, as before and likely cysts.No new hepatic abnormality.The hepatic size and enhancement were normal.The gallbladder has been removed.No bile duct dilatation or bile duct stone.The splenic size and enhancement were normal.No focal splenic abnormality.There was no focal pancreas abnormality or pancreatic duct dilatation.The adrenal glands were normal.There were no calcifications in the kidneys or in the ureters.No hydronephrosis or hydroureter.No renal cortical abnormality.The enhancement of the kidneys was normal.There was vascular calcification but no abdominal aortic or iliac artery aneurysm.No retroperitoneal lymphadenopathy.There was moderate feces in the colon.Fluid was noted in the small bowel loops but no bowel dilatation to suggest obstruction.No evidence of free intraperitoneal gas.The appendix was not visualized.There was no pericecal inflammation.No evidence of mesenteric lymphadenopathy.Pelvis ct findings include the uterus has been removed.No adnexal mass, pelvic free fluid or fluid collection.No pelvic or inguinal lymphadenopathy.No focal bladder abnormality or bladder calculus.There are surgical clips in the right groin from hernia repair.No abdominal wall or inguinal hernia.Impressions include fluid in small bowel loops but no bowel obstruction or free air.The patient was constipated.The appendix was not visualized but no secondary features to indicate appendicitis.No renal, ureteral or bladder calculus.Additional findings include cholecystectomy, hysterectomy, atherosclerosis and a stable tiny hypodensities in the liver likely cysts.In the physician's assessment, the patient had hematochezia.The patient was stable and was discharged.Prescription was provided which included bentyl 20 mg oral tablet (prescribe): 20 mg, 1 tab(s), oral, every six hour (interval), as needed for abdominal pain, 24 tab(s), 0 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up for rectal bleeding.Discussed lesions and would like a drug screen.She has had prurigo nodules on face, chest which have intermittently become infected with oozing green material, swelling, redness.She has been on and off with oral antibiotics for much of this year.At her last visit the physician advised no further antibiotics until seen by infectious disease specialist, but she stated that her gyne surgeon in seattle did place her back on keflex until she could see the specialist.She did state that this improved the lesions.Since last visit she had knee scope and was doing very well.No adverse problems were noted.Great improvement in pain and mobility.The patient had 6 week follow up with surgeon yesterday.She was seen at the emergency room last night for hematochezia and pelvic pain.Laboratory results were normal, ct of the abdomen showed constipation but no acute findings.She describes brbpr, but no rectal pain or itching.She denied melena, nausea and vomiting.Her chronic pelvic pain was noted ever since a mesh in pelvis became infected and resulted in scar tissue.She stated the pain and bleeding completely resolved with use of bentyl.She did note bowel movement changes ever since she started post operative pain medications.Regarding the chronic pelvic pain, she discussed pain management with her surgeon, but she did not want to go back on opioids and was given a nerve pain medication but did not take it.She wanted to seek medical clearance for cbd/ marijuana.The patient also requested drug testing.She did have past history of cocaine use, and current marijuana use.She was on post operation pain medication.Stated she has been accused by multiple medical facilities and others of illicit drug use and wants to get verified proof that this was incorrect.The patient was due for lipids, hep c test.The patient's assessment and plan included the following: for the irritable bowel syndrome, work up was negative, stated all symptoms resolved.Likely this was secondary to constipation from recent pain medications, could be internal hemorrhoid.Declined examination today as she was doing better.Will check stool tests given ongoing stool changes, pain, and recent exposures.Advised to continue the bentyl as needed.Advised to increase fiber or use over-the-counter miralax for constipation and to increase fluids.For the skin lesion, a follow up with dermatologist and id was advised with no appearance of infection today.For fibromyalgia, discussed options.She did not want to seek medication for her chronic pain and pelvic pain.She wanted clearance for medical marijuana, but the physician cannot do this.She will seek opinion in olympia.The patient was seen and examined on (b)(6) 2018 for a follow-up on her pelvic pain, urinary incontinence and rectal bleeding.She underwent (total abdominal hysterectomy) tah for endometriosis in 2008.Six months later in 2008, she then had what sounds like tot sling for urinary incontinence with mesh.The patient stated that her problems started after that surgery.She then had sling mesh removal in (b)(6) 2018.She has felt much improved since that surgery but needed to have a urethral reconstruction.She was awaiting for that surgery.She has urinary incontinence and has to wear depends daily.Last pap smear was on (b)(6) 2017 with negative/negative.Mammogram was (b)(6) 2018, negative.Denied breast complaints.Assessment and plan of the physician included a well woman examination without gynecological examination.No pap smear needed until (b)(6) 2022.Normal breast examination.Needed screening mammogram in (b)(6) 2019.Urgency incontinence will follow-up at another healthcare facility.Pelvic and perineal pain.Rectal bleeding and was advised to see her gi specialist on (b)(6) 2018.The patient was seen and examined on (b)(6) 2018 for continuing management of prurigo nodularis - excoriated papules and occasionally draining ulcers- on right cheek, right chest, and previous on back, thighs.In the physician's assessment, the question of sweets or another neutrophilic dermatosis.While not present at their appointments, her interim severe swelling could be consistent.Recommend biopsy of new area of rash for definitive diagnosis but she was hesitant, would like to defer today.Reviewed that diagnosis was important (rec biopsy) then treatment options could include oral dapsone, oral colchicine, and other oral immunosuppressants.Scheduled for three upcoming surgeries in the next six weeks, would not recommend starting immunosuppressants until after these procedures.They discussed about prescribing her sulfadiazine and dapsone creams.Risks, benefits, and alternatives reviewed today.Advised to not pick on the lesions on her right cheek.Initiated sulfadiazine 1% cream to open skin two times a day.Ordered today.Initiated dapsone 5% gel to boils two times a day.Ordered today.Silver sulfadiazine 1% external cream; to open skin twice daily dispense: 50 gm.Refill: 5.Dapsone 5% external gel; to boils on skin twice daily dispense: 60 gm; refill: advised for skin culture and sensitivity test with gram.As for the patient's prurigo nodularis, the patient reported boils on her back consistent with prurigo nodularis.Patient will be having surgery on (b)(6).Biopsy offered, patient declined, plan at follow up in six weeks.Advised to discontinue oral cephalexln for now until after her surgery.Return to clinic in (b)(6) 2018 or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2018 for a follow up on several issues and to get clearance for dental surgery (root canal).Since her last visit she underwent colonoscopy in seattle for rectal bleeding.She was found to have multiple internal hemorrhoids.She stated that she referred her back to her normal gastroenterologist for follow-up on this.She has also been seeing infectious disease specialist in olympia.She was started on topical dapsone and continued on chlorhexidine washes.She stated that she'll be following up with him after surgery from her slowest in seattle for removal of mesh, which has been the source of ongoing infection.She stated that she was diagnosed with sweet syndrome following multiple tests.She will be following up with specialists in the next week or two.The patient was seen and examined on (b)(6) 2018 for preoperative examination.She'll be seeing her urine gynecologist at virginia mason for removal of infected mesh and rectocele correction.History significant for sweets syndrome, seizure in response to sodium pentothal, fibromyalgia and urinary incontinence.She was currently being followed by gynecology, infectious disease and dermatology.She was currently continuing to experience lower abdominal pain and cramping.She denied any dysuria nor hematuria.She did recently underwent banding of hemorrhoids which was extremely successful.Since then hematochezia or rectal pain was noted.She has no cardiovascular history.She stopped smoking but did continue to use a vaporizer.She was able to complete all of her tasks by herself at home.Ekg in office today was normal.She was advised to get her labs done as previously requested by her surgeon.If needed, they can reorder this when necessary.Physical examination unremarkable.She has argument with her surgeon regarding stopping current medications before the surgery.She was low cardiovascular risk.Advised to avoid sodium pentathol, but otherwise no contraindications.The physician filled out her form for the surgeon.She wondered about home health, advised to discuss with surgeon first the physician was unsure with her recovery and expected limitations.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of january 8, 2018 was chosen as a best estimate based on the date of the mesh removal surgery.Block b5 continuation: the patient was seen and examined on march 13, 2019 for prurigo nodularis.She was last seen on october 5, 2018, at which time she was provided sulfadiazine 1% cream to be applied twice a day to open skin and dapsone 5% gel to boils twice a day.She was recommended to consider biopsy or other oral immunosuppressants if her skin erosions were not improving.Since the last visit, she saw an infection specialist at virginia mason who recommended that she stop her antibiotics.After a week, her face started to swell, so she restarted the medication about two days ago.She was now taking doxycycline and applying dapsone, the infection specialist also referred her to rheumatology.She had a biopsy on 2004, showing sweet's syndrome.In the physician's assessment, biopsy proven sweet's syndrome by 2004 pathology report.Possibly now rosacea, boils, or sweet's.Recommend she continue cephalexin 500 mg daily and topical dapsone.Discussed the risk of antibiotic resistance with long term antibiotic use.For further improvement, recommend she initiate dapsone 25 mg daily.Usually tolerated well but can cause suppression to the bone marrow.Risks, benefits, and alternatives reviewed.Offered injections today to calm the flare.Patient accepted.Considered tapering down on cephalexin at next visit.The patient was seen and examined in the emergency room on march 23, 2019 for an intolerable pain and her pcp cannot help.The patient had a history of irritable bowel syndrome, lupus, and a major abdominal surgery several months ago and presented for an oxycodone refill.Stated that she was allergic to ibuprofen, and she was taking as much tylenol as she can.She got her medications filled regularly by a physician and per edie review, last refill was a week and half ago.She was out of the medication and was having "severe" abdominal pain.Located over this site of her last surgery, no new symptoms including nausea, vomiting, changes in stool nor urination.Stated it was her chronic pain that she needed the medication refill for.Advised the patient that the physician cannot do narcotic refills.She denied any new symptoms or new pain.The patient was seen and examined on april 23, 2019 for continued management of prurigo nodularis.In the physician's assessment, the patient had a good response to kenalog injection, well-controlled with prednisone.Discussed that after lesions became under control, the next step was tapering dapsone.Patient was able to stop taking antibiotics since her last visit.Ilk offered today and patient accepted.Continue dapsone 25 mg daily and topical dapsone.Injection of intralesional up to and include seven lesions.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection was given.Return to clinic in six weeks for prurigo nodularis or sooner as needed for acute concerns.The patient was seen and examined on july 1, 2019 for continued management of prurigo nodularis.In the physician's assessment, the patient had much improved with dapsone treatment.Good response to kenalog injection, well-controlled with prednisone.Discussed that after lesions become under control, the next step was tapering dapsone.Ilk offered today and patient accepted.Three spots on right cheek, right chest x 2.Continue dapsone 25 mg oral tab; take 2 tablets (50 mg) by mouth daily.Dispense: 60 tablets; refill: 2.Injection of intralesional up to and include seven lesions.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection was given.Labs ordered include cbc with differential.Comprehensive metabolic panel, and reticulocyte count.Return to clinic in eight weeks for prurigo nodularis or sooner as needed for acute concerns.The patient was seen and examined on august 29, 2019 for check up and would like to discuss medical problems and was told she needed to have knee surgery again.The patient had chronic pelvic pain and neurologic discomfort after a mesh implant became infected and had to be removed.She underwent several surgeries in the last year, and the physician started her on gabapentin for the pain.Overall, she felt much better.The left sided burning pain has resolved.However, she still has right sided pelvic pain.She saw a surgeon again in two weeks.She saw her dermatologist and id for sweet's disease and chronic lesions.These were being injected with steroids and treatment with dapsone.She was seeing ortho locally for chronic knee pain.She was finishing up pt and was set to see the surgeon again soon.In the physician's assessment, the patient needed to continue gabapentin and has been much improved.The patient was requesting to try something else to help with the ongoing right-side pain.Will try low dose amitriptyline.Follow up with surgeon was advised.The patient wanted to avoid chronic opiod if possible, if not controlled the patient could consider pain clinic evaluation.Amitriptyline 25 mg oral tablet, (25 mg) 1 tab(s), oral, once a day (at bedtime) was prescribed for chronic pain.Instructions for pain, #30 tab(s), 3 refill(s).The patient was seen and examined on september 13, 2019 for continued management of sweet's syndrome with associated prurigo nodutaris.Since the last visit, she noted that her sweet's syndrome has been flaring for about a week.She developed new lesions on her left cheek and central chest, and her existing lesions have increased in size.The lesions on her left cheek and on her right anterior thigh have been particularly painful.Her lymph nodes have been swollen during this period.She has been taking cephalexin with benefit.She denied any numbness and fatigue associated with her dapsone usage.In the physician's assessment, the patient has been experiencing a flare of her sweet's syndrome for the last week, and noted the development and worsening of lesions on her right thigh, chest, and bilateral cheeks.Upon examination, she has slight swelling around her jaw and excoriated plaques to the bilateral cheeks, right anterior thigh, and chest.Recommended she begin colchicine in addition to continuing her dapsone regimen.For acute treatment of the flare.In her condition, the patient would like to pursue intralesional kenalog injections.Ilk injections offered today and patient accepted.Ilk given was 2 ml (5 mg/ml) for a total of 10 mg.Continue dapsone 25 mg daily and topical dapsone.Colchicine 0.6 mg oral tablet; take 1 tablet (0.6 mg) by mouth two times a day.Dispense: 60 tablets; refill: 2.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection.Injection of intralesional up to and include seven lesions.The patient was advised to return to the clinic in six weeks or sooner as needed for acute concerns.The patient was seen and examined on october 25, 2019 for sweet's syndrome and prurigo nodularis.Since the last visit, she started taking the colchicine 0.6 mg and reported that her sweet's and prurigo nodularis has improved significantly.She had random breakouts last week on her chest, left cheek, and left lip and she reported that these lesions are "flaky" off much quicker.In the physician's assessment, the prurigo nodularis and sweet's syndrome improved on dapsone 25 mg twice a day and colchicine 0.6 mg.Recommend she continue.Risks of medications were reviewed.She will let the physician know if she became fatigued or if she noticed numbness and tingling.The patient was advised to return to the clinic in eight weeks or sooner as needed for acute concerns.The patient was seen and examined on december 2, 2019 for continued management of sweet's syndrome and prurigo nodularis.Since the last visit, she reported that she did not increase her dose of dapsone.She has noticed that the lesion on her left cheek has on gotten worse.She has also noticed a new lesion on her right cheek.She thought that these flare up more with stress.She was having surgery on her left knee this week, which was causing her to be more stressed than usual.No new treatments have been tried.Given she was having surgery this week, the physician recommend that she not change anything with her medications until afterwards.The patient was seen and examined on january 13, 2020 for continued management of sweet's syndrome and prurigo nodularis.Since the last visit, the lesions on her right and left cheek have returned.She has noticed that the lesion on her right cheek in particular has become harder.She has also noticed there was a lesion on her chest.She has noticed that when she was stressed it made these lesions worse.No treatments have been tried.Exacerbation factors unknown.The patient had a recent knee surgery that went well.In the physician's assessment, the patient was stable overall.The patient flared a bit with stress (e.G.Recent knee surgery).Tolerating dapsone well, no nausea nor vomiting, shortness of breath, increased fatigue at 50 mg daily.The patient presented today with a worsening lesion on her left and right cheek and her chest.She thought that the lesions flare under stress.Given that ilk has been beneficial in the past, the physician recommend that they do ilk injections today and patient accepted.The patient was advised to return to the clinic in four to six weeks or sooner as needed for acute concerns.The patient was seen and examined on january 24, 2020 for follow up on problems due to the mesh and discuss the gabapentin she stopped due to side effects which was giving her breathing problems.Patient was also concerned about her weight loss.The patient has history of chronic pelvic neuropathic pain.She has history of a mesh was which was placed, became infected and has caused ongoing problems.She continued to follow up with her surgeon in seattle.She stated she recently had a follow-up and was advised to follow-up in the next month or two for her one-year checkup.There has been minimal improvement since the surgery.Pain was severe and daily, burning and deep in nature.She was placed on gabapentin for this which was helpful however she did not wish to take this medication anymore.She stated that it caused her respiratory distress as well as dizziness.She has stopped completely and was taking three tablets/day.She also stated that she has a seizure disorder.The physician has not witnessed seizure nor saw neurology notes confirming this.She has had no recent seizure activity.She would like to change to a different seizure medication.She recently had knee surgery with orthopedist.She stated this was healing well.She was currently on a crutch.In the physician's assessment, the patient has not had seizures while on gabapentin.The physician will titrate her off and changed to trileptal as this may help with her neuropathic pain as well.Going to place referral to a neurologist for formal seizure work-up and recommendation.The physician would also like if they could address her neuropathic pain.They did discuss pain clinic as a possibility.She was instructed to call her surgeon for her yearly follow-up.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.Carleen t.Bensen olympic medical center 939 caroline st.Port angeles, wa 98362 the explant surgeon is: una lee, md virginia mason medical center 1100 ninth avenue seattle, wa 98101 usa +1(888) 862-2737 block h6: patient code e2401 captures the reportable event of unknown injury patient code e172001 captures the reportable event of abscess.Patient code e230901 captures the reportable event of calcification.Patient code e0701 captures the reportable event of respiratory distress.Patient code e2330 captures the reportable event of pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e2339 captures the reportable event of ulcer.Patient code e1906 captures the reportable event of infection.Patient code e2326 captures the reportable event of inflammation.Patient code e1710 captures the reportable event of lesion.Patient code e0122 captures the reportable event of movement disorder.Patient code e1705 captures the reportable event of burning sensation.Patient code e2312 captures the reportable event of fatigue.Patient code e230101 captures the reportable event of fever.Patient code e1715 captures the reportable event of scar tissue.Patient code e2315 captures the reportable event of fluid discharge.Patient code e0123 captures the reportable event of nerve damage.Patient codee2338 captures the reportable event of swelling.Patient code e0506 captures the reportable event of hemorrhage.Impact code f2303 captures the reportable event of medication required.Impact code f1202 captures the reportable event of disability.Impact code f1901 captures the reportable event of additional surgery.Impact code f1903 captures the reportable event of device explantation.Impact code f1903 captures the reportable event of mesh removal.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks h6 and h10 (reportable codes) have been corrected based on medical safety review on november 16, 2022.Block h6: patient code e172001 captures the reportable event of abscess.Patient code e2330 captures the reportable event of pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e2339 captures the reportable event of ulcer.Patient code e1906 captures the reportable event of infection.Patient code e2326 captures the reportable event of inflammation.Patient code e1710 captures the reportable event of lesion.Patient code e1705 captures the reportable event of burning sensation.Patient code e2312 captures the reportable event of fatigue.Patient code e230101 captures the reportable event of fever.Patient code e1715 captures the reportable event of scar tissue.Patient code e2315 captures the reportable event of fluid discharge.Patient code e0123 captures the reportable event of nerve damage.Patient codee2338 captures the reportable event of swelling.Patient code e0506 captures the reportable event of hemorrhage.Impact code f2303 captures the reportable event of medication required.Impact code f1202 captures the reportable event of disability.Impact code f1901 captures the reportable event of additional surgery.Impact code f1903 captures the reportable event of device explantation.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6) 2008.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on (b)(6) 2018.Additional information received on august 8, 2022.It was reported to boston scientific corporation that obtryx system - halo device was implanted into the patient during a transobturator suburethral sling procedure performed on (b)(6) 2008 for the treatment of cystocele and stress urinary incontinence.As reported by the patient's attorney, the patient experienced an unknown injury and had a mesh removal surgery on (b)(6) 2018.Additional information received on october 11, 2022.The patient was seen and examined on (b)(6) 2017 for bladder leakage.The patient has had bladder mesh placed in 2008.Has leakage with coughing and sneezing.The patient presented with an overactive bladder.The overactive bladder was described as voiding 12 times per day, wetting clothes frequently and wearing pads.The severity of the overactive bladder was severe.The overactive bladder was worsening.The overactive bladder has lasted for 3 month(s) and worse, which actually began a year ago.Associated symptoms consisted of bladder dysfunction.The patient has had a hysterectomy and the last menstrual period was not applicable.Last menstrual period secondary to endometriosis.She presented today for evaluation.The physician discussed the kinds of incontinence of urine including overactive bladder and overflow incontinence which could all manifest in this way.She was made aware the approaches to these problems might be different and so they need to evaluate with a urodynamic study.She will be scheduled appropriately.On (b)(6) 2017, the patient called and stated to the nurse on the phone she had went to the uw to see a specialist for her abnormal bleeding and to discuss a vaginal mesh that was faulty.She stated she did not want to see her previous physician as they did not believe her concerns and said she found her symptoms on the internet.The patient stated she wanted to see another physician who can remove the faulty mesh and help her with the bleeding she has.Appointment was set up for thursday, november 16, 2017.The patient was seen and examined in the emergency room on (b)(6) 2017 for lower abdominal pain for four hours.The patient stated the pain was 10/10 at this time.The patient stated pain was from her bladder mesh sling eroding into stomach.The patient stated pcp sent her here for evaluation.The patient also stated rectal bleeding.In the physician's assessment, the patient had chronic pelvic pain.She was prescribed with norco 5 mg-325 mg oral tablet (prescribe): 1 tab(s), oral, every 6 hours (interval), as needed for pain, 15 tab(s), 0 refill(s).Patient was given the educational materials for pelvic pain.A follow up with the physician as needed and to call for follow up appointment.On (b)(6) 2018, the patient underwent an excision of transobturator mesh sling and cystourethroscopy.Her pre- and post-operative diagnosis was pelvic pain, groin pain, abdominal pain, and history of prior transobturator sling placement.The patient had a history of tobacco use and chronic pain.She was evaluated and found to have tenderness with palpation of her sling that recreated some of her groin pain.She understands that her incontinence may be affected and this may or may not alleviate her pain symptoms.After risks and alternatives were discussed with patient, she agreed to proceed with the above procedure.Procedure findings include the urethral vaginal portions of her mesh sling were removed in entirety and aggressively into the obturator foramen via the transvaginal approach.Cystourethroscopy was within normal limits without any acute findings.During the procedure, the patient was correctly identified by name and date of birth and brought to the operating room.General anesthesia was induced, and she was positioned in dorsal lithotomy position, prepped and draped in standard sterile fashion.Appropriate antibiotics were administered.A virginia mason surgical pause was conducted.They started the procedure by getting vaginal exposure with a lone star retractor, blue hooks, and a foley catheter was left to gravity drainage.The physician could palpate a band-like structure consistent with a mesh sling.The physician made two lateral oblique incisions in the periurethral area and extended these laterally.They could palpate the sling with the tips of their metzenbaum scissors.The physician then dissected it between the two lateral oblique incisions under the urethra and converted this to an inverted u incision.The physician made an anterior vaginal wall flap.The physician could visualize the mesh sling.The physician dissected it out.It was quite adherent.The physician made an incision in the mesh sling in the right lateral periurethral area.The physician dissected out the patient's left arm of the sling aggressively into the obturator foramen.It was quite inflamed in the groin area.The physician carefully dissected the mesh sling away from her urethral vaginal tissues.The physician went approximately one centimeter beyond the foramen and isolated the mesh away from her tissues and then excised it and truncated it with the curved mayo scissors.The physician sent this off as a specimen; it was approximately five centimeter in length.The physician went back to the right arm of the sling, and they dissected it away from the tissues, away from the urethra and the vagina.It was also adherent and inflamed.The physician brought this out to the groin on her right side and dissected it free from the obturator foramen, approximately one centimeter beyond, and excised it.This was approximately 2.5 cm in length for a total length of 7-8 cm of mesh removed.They irrigated the wound.Hemostasis was excellent.We then reapproximated the periurethral fascia of the urethra where the groove where the sling was.This was done with several interrupted #3-0 vicryl sutures.The physician then performed cystourethroscopy, which revealed no acute findings of the urethra or bladder, normal bilateral urinary orifices.The physician then advanced the anterior vaginal wall flap and closed in a running interrupted fashion with #2-0 vicryl.A final foley catheter closed system was placed.Vaginal packing with premarin cream was also placed in the vagina.The patient was awoken from general anesthesia and transferred to her room in excellent condition.There were no complications at the end of the procedure.On (b)(6) 2018, the patient was seen and examined that day for itchy open sores on her skin since march of 2017.It started on her right thigh, now spreading throughout her body to mid/lower back, and right cheek.The patient had a history of chronic infection.The mesh removed two weeks prior.Itching, skin problems, fatigue, pain, gastrointestinal upset all much improved since then.The patient had a history of autoimmune problem, initially thought to be systemic lupus erythematosus, which was later diagnosed as mixed connective tissue disease.No history of skin disease like this in past, and the patient asked if it was related.Etiology and chronic irritation of prurigo nodularis was reviewed from friction, rubbing or trauma.It was also reviewed not touching the area as able.Treatment options were reviewed including to watch for occlusive patch, intralesional triamcinolone and shave removal.The patient elects to try watchful, waiting and minimizing trauma for now.After risks, benefits, and alternatives reviewed and consent, intralesional triacinolone acetonide 10 mg/ml x 0.5 ml injected via 30-guage needle into the five inflamed papules.As for the patient's mixed connective tissue disease, there were no evidence of cutaneous findings.Reassurance was given that there was no evidence of progression of her disease.Recommended routine physicals and further screening based on symptoms and to return to the clinic as needed.The patient was seen and examined on (b)(6) 2018 for a follow up after surgery to help with mesh removal in the pelvis.She has chronic pain due to mesh placement to help with urinary incontinence years ago.She has been working with the surgeon up in seattle and they removed most of the mesh on (b)(6) 2018.She stated that her pain was significantly improved.She was not taking any opiates at this time.Her primary reason for presenting today was because she was upset about a phone call that she received from our office within the last couple weeks.They had given her norco no.30 for her continued pelvic pain.On the same day, they did a urinalysis to make sure it would be used properly and safely.Utox revealed she was positive both for breakdown products of norco and alcohol.She was then contacted and reminded that the combination of these two medicines were exceptionally dangerous and that if they saw this again, they would no longer be able to give her opiates for pain.The primary reason for calling was for her education due to concerns for her safety.They already discussed with her at the prior visit were not going to fill her opiates long-term without either her current surgeon working on her pelvic pain with her or a pain specialist stating that it was appropriate.She felt offended by the phone call.She repeatedly stated that they just think she was a drug seeker.She did have a history of pain management with opiates and voluntarily quit that.She stated that the norco they gave her wasn't really strong enough to touch her pain anyway and that her pain was a 12-13 out of 10 though she stated that she sure everybody said that.She did not request opiates today.She was using tylenol for pain relief.Suggested to her that this has been a misunderstanding.She accepted that.They will refill her acetaminophen today and instructed to take 1-2 tabs orally every four hours as needed for pain and not to exceed 4000 mg/day, #360 tab(s), 11 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up from emergency room for a face infection she has been treated and it has gotten better but not completely gone.The patient had a long history of skin problems who was seen and examined on (b)(6) 2018 to follow-up on recent treatment of cellulitis of the right face.The cellulitis appeared to have started with a prurigo nodule as diagnosed.Unfortunately, the nodule eventually resulted in an infection.The infection spread to cover much of her face.She was treated with bactrim and bactroban initially but without much improvement.Two days later when she was back in the emergency room, augmentin was added.The augmentin began to decrease the inflammation and erythema and treat the infection.She had slow improvement over the course of the next approximately two weeks.At that point, she felt like it might be getting worse so she came back into the walk-in clinic.The physician gave her a single dose of im ceftriaxone and attempted to culture the wound.The wound culture thus far showed 2+ coagulase negative staph.Since that time, she felt like the erythema has completely dissipated reversing the course of the couple days prior to the ceftriaxone.She reported today but the physician cannot confirm if that the nodule on her cheek was treated with steroids shortly before all this happened.Remained unclear why she was having these nodules.She did have surgery planned to remove what was remaining of the mesh.Upon examination, there was a tiny 0.1 cm ulceration in her right cheek with a little bit of erythema around that approximately 1 cm though the erythema was not warm and certainly not bright.This was almost the same color as her surrounding skin.The physician tried to express anything from the wound but nothing was able to come out.She did have some tenderness with this.At this time, it looked like the cellulitis was probably adequately resolved.The physician did not think further antibiotics was needed.She should continue hibiclens treatment once a week to help prevent recurrent infections due to her nodules.Discontinue out when dermatology the dove fills appropriate.Hopefully, these nodules will cease or at least slow down significantly after she has remainder of the mesh removed from her body.The patient was seen and examined on (b)(6) 2018 for a follow up for lesions on face, chest and knee.This has been an ongoing problem for her, for which she saw a specialist in seattle.The problem seemed to stem from prurigo nodules, which become infected.Last month, she was treated with oral antibiotics for infection in these lesions, however this was not completely effective so she presented to clinic and received an injection of 1 gm rocefin, which she stated completely reversed the infection.Over the past week, she was again experiencing swelling, redness, and pain in the right cheek.She did note discharge of yellow fluid from the wounds.She will also have a follow up with her skin specialist a week later.At the april 12, 2018 visit, she was also assessed for severe exacerbation of left knee pain.She was to be given with im rocephin 1 gm that day for cellulitis which the patient tolerated well with no complications.Follow up with specialist in seattle next week.May continue topical therapy and was sent prescription for keflex.Follow up if not improving.Prescription was given for cephalexin, (500 mg) 1 cap(s), oral, every eight hour (interval), for 5 day(s), #15 cap(s), 0 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up ongoing infection.Discussed stronger antibiotic for face.Since her last visit she did see her specialist in seattle (surgeon, not dermatologist), who advised rather invasive surgery from how patient described, though at this time the physician did not have documents from specialist to reference.There was thought that the source of recurrent infection was retained mesh.She last received im rocephin 2 weeks ago, and noted significant improvement in the pain, swelling, redness of the prurigo lesions.She has a follow up with a dermatologist next month.She continued hibiclens and mupirocin.She noted the facial lesions has become more painful, and she was concerned it was more infected.However, the patient had no fever or chill, and there was no drainage.Upon examination, the patient had a right facial lesion, with some darkened discoloration and sunken appearance next to slightly red raised nodule with shallow ulcer.No surrounding erythema.No discharge.No streaking redness.Nontender.No other lesions noted.In the physician's assessment, he was not convinced that further antibiotic was totally necessary at this point.She may continue the hibiclens and the mupirocin.She has a follow up with a dermatologist next month.If things were getting worse in the meantime, the patient could consider another course of oral antibiotics or another rocephin injection if needed.The patient was seen and examined on (b)(6) 2018 for a follow up of prurigo nodules on trunk, legs, and face.Last visit was on (b)(6) 2018 with the physician for same.The patient had intralesional triamcinolone at that time.Since last visit, has a new diagnosis of infected mesh in her body and was scheduled for surgery next month.The patient has been on extensive antibiotics, most recently keflex, with good response to cheek bumps.Bumps on trunk, leg resolved; those on right cheek, especially one nodule, persisted with pain and itching.Her gyne team recommended no further intralesional triamcinolone until mesh problem was addressed.Upon examination, the patient had a one-centimeter subcutaneous nodule on the right cheek with overlying angulated erosion.The remainder of skin areas examined were unremarkable.The following impression and plan were provided by the physician which included injection of intralesional up to and include seven lesions likely cyst versus furuncle versus staph, though multiple bacterial culture negative keflex appeared to be helping, continue with this treatment.Continue with hibiclens weekly.For acute control of pain and itching, intralesional lidocaine 2% x 1 ml injected into right cheek nodule.Return to clinic in 8 weeks after upcoming surgery or as needed.The patient was seen and examined on (b)(6) 2018 for a follow up on chronic skin infection.She was last placed on keflex for her ongoing facial cellulitis and prurigo lesion.She was in consultation with the surgeon in seattle to remove the mesh from the pelvis which they believe may be causing some ongoing infections.She was also seen by a dermatologist in seattle who she states has recommended she continue the keflex until she underwent surgery.At this point, the physician had no notes from these providers.She stated that after finishing the antibiotics, a few days later she developed severe swelling and redness of the face, node swelling, fevers, chills, fatigue, new skin lesions which were draining green material.She presented to the emergency room and was given iv antibiotics, and was advised to continue the keflex.At this point, she noted no further drainage, no new lesions, no further fevers or chills.Upon examination, it was noted that the patient had a chronic lesion on the right cheek.A small erythematous papule with excoriation but no discharge central chest.Assessment and plan of the physician included a refill of her antibiotic, and was advised that she follow-up with her dermatologist to consider appropriate chronic care.Follow-up with the surgeon for removal of the mesh.Orders include cephalexin, (500 mg) 1 cap(s), oral, every 12 hour (interval) for 14 day(s), #28 cap(s), 0 refill(s).Medication side effects were addressed, and the patient was agreeable to the above plan.All questions were addressed during the visit.The patient was seen and examined on (b)(6) 2018 for prurigo nodularis with excoriations and secondary infections, last visit with the physician was two months prior.Since the last visit she was taken off the antibiotics a week ago and then she worsened.Her temperature was over 99-degress fahrenheit.She noted new lesions on her thigh.She was becoming "sicker by the day".No surgeries at this time.Time.She noted that the mesh inside her was infected.She noted the antibiotics was working and the lesions were resolving.She noted the lesions were painful.She was now allergic to cortisone.She took antibiotics (cephalexin) twice a day and would like to restart.Upon examination, fullness on the right neck lymph was noted versus abscess.Her right anterior thigh was noted to have an angulated erosion.Recommendations for the patient's assessment and plan included the following: for prurigo nodularis (right thigh), unfortunately her lesions were worsening.Differential diagnosis including increased picking and secondary infection.She reported that she was also allergic to cortisone and will develop flu-like symptoms upon use, so the physician will stop ilk injections at this time.Patient was concerned for possible infection.She noted that she was worsening.She will be restarted on antibiotics today due to cough and fullness of the right neck.A culture was taken from her right anterior thigh to check for infectious agents and of throat, the patient was prescribed with cephalexin 500mg capsules twice a day, cephalexin 500 mg oral capsule; to take one capsule (500 mg) by mouth two times a day and dispensed 60 capsules with 5 refills.Skin culture and sensitivity test with gram was advised and patient agreed with the evaluation with identification in future to consider staph eradication protocol.The patient could do well with bleach baths and was reviewed today.For lymphadenopathy of right cervical region, the patient reported that she was worsening and on exam has shown cough and increased fullness of the right neck.Patient was going to follow up with infectious disease specialist who will assess her.Culture was ordered and swabbed from throat.The patient was expected to return to clinic in four weeks or sooner as needed for acute concerns.The patient presented to the emergency department complaining of suprapubic and right lower quadrant abdominal pain along with bright red blood per rectum.Two years ago, she had intermittent rectal bleeding.Eventually, it was determined to be related to a vaginal mesh that had been placed, so in january of this year she had the mesh removed.She reported that they were unable to remove the entirety of the mesh because some of it was embedded into tissue close to some nerves.Following the surgery, she developed some sort of infection, so a planned procedure to remove the rest of the mesh was canceled and rescheduled for november of this year.For the past two days, she has had some suprapubic and right lower quadrant abdominal pain.This morning she noticed that she was again passing blood with her stools.She also noted more blood this evening and decided it was prudent to come to the emergency department for evaluation.The patient described her abdominal pain was a combination of sharp and crampy.She reported that she was in pain approximately 50% of the time.The episodes of pain last to three minutes and then go away for 2-3 minutes.She can both exacerbate or bring on the pain by palpating her right lower quadrant and suprapubic area.Patient denied any vaginal bleeding.She denied any dysuria, urgency, frequency, or other gastro urinary complaints.The patient has not had fevers.She reported that she has been on multiple antibiotics continuously since her surgery in january.Currently, she was taking cephalexin.Abdominal ct findings include the lung bases and visualized mediastinum the mild atelectasis at the lung bases.No pleural or pericardial effusion.The heart size was normal.There were tiny hypodensities in the liver, as before and likely cysts.No new hepatic abnormality.The hepatic size and enhancement were normal.The gallbladder has been removed.No bile duct dilatation or bile duct stone.The splenic size and enhancement were normal.No focal splenic abnormality.There was no focal pancreas abnormality or pancreatic duct dilatation.The adrenal glands were normal.There were no calcifications in the kidneys or in the ureters.No hydronephrosis or hydroureter.No renal cortical abnormality.The enhancement of the kidneys was normal.There was vascular calcification but no abdominal aortic or iliac artery aneurysm.No retroperitoneal lymphadenopathy.There was moderate feces in the colon.Fluid was noted in the small bowel loops but no bowel dilatation to suggest obstruction.No evidence of free intraperitoneal gas.The appendix was not visualized.There was no pericecal inflammation.No evidence of mesenteric lymphadenopathy.Pelvis ct findings include the uterus has been removed.No adnexal mass, pelvic free fluid or fluid collection.No pelvic or inguinal lymphadenopathy.No focal bladder abnormality or bladder calculus.There are surgical clips in the right groin from hernia repair.No abdominal wall or inguinal hernia.Impressions include fluid in small bowel loops but no bowel obstruction or free air.The patient was constipated.The appendix was not visualized but no secondary features to indicate appendicitis.No renal, ureteral or bladder calculus.Additional findings include cholecystectomy, hysterectomy, atherosclerosis and a stable tiny hypodensities in the liver likely cysts.In the physician's assessment, the patient had hematochezia.The patient was stable and was discharged.Prescription was provided which included bentyl 20 mg oral tablet (prescribe): 20 mg, 1 tab(s), oral, every six hour (interval), as needed for abdominal pain, 24 tab(s), 0 refill(s).The patient was seen and examined on (b)(6) 2018 for a follow up for rectal bleeding.Discussed lesions and would like a drug screen.She has had prurigo nodules on face, chest which have intermittently become infected with oozing green material, swelling, redness.She has been on and off with oral antibiotics for much of this year.At her last visit the physician advised no further antibiotics until seen by infectious disease specialist, but she stated that her gyne surgeon in seattle did place her back on keflex until she could see the specialist.She did state that this improved the lesions.Since last visit she had knee scope and was doing very well.No adverse problems were noted.Great improvement in pain and mobility.The patient had 6 week follow up with surgeon yesterday.She was seen at the emergency room last night for hematochezia and pelvic pain.Laboratory results were normal, ct of the abdomen showed constipation but no acute findings.She describes brbpr, but no rectal pain or itching.She denied melena, nausea and vomiting.Her chronic pelvic pain was noted ever since a mesh in pelvis became infected and resulted in scar tissue.She stated the pain and bleeding completely resolved with use of bentyl.She did note bowel movement changes ever since she started post operative pain medications.Regarding the chronic pelvic pain, she discussed pain management with her surgeon, but she did not want to go back on opioids and was given a nerve pain medication but did not take it.She wanted to seek medical clearance for cbd/ marijuana.The patient also requested drug testing.She did have past history of cocaine use, and current marijuana use.She was on post operation pain medication.Stated she has been accused by multiple medical facilities and others of illicit drug use and wants to get verified proof that this was incorrect.The patient was due for lipids, hep c test.The patient's assessment and plan included the following: for the irritable bowel syndrome, work up was negative, stated all symptoms resolved.Likely this was secondary to constipation from recent pain medications, could be internal hemorrhoid.Declined examination today as she was doing better.Will check stool tests given ongoing stool changes, pain, and recent exposures.Advised to continue the bentyl as needed.Advised to increase fiber or use over-the-counter miralax for constipation and to increase fluids.For the skin lesion, a follow up with dermatologist and id was advised with no appearance of infection today.For fibromyalgia, discussed options.She did not want to seek medication for her chronic pain and pelvic pain.She wanted clearance for medical marijuana, but the physician cannot do this.She will seek opinion in olympia.The patient was seen and examined on (b)(6) 2018 for a follow-up on her pelvic pain, urinary incontinence and rectal bleeding.She underwent (total abdominal hysterectomy) tah for endometriosis in 2008.Six months later in 2008, she then had what sounds like tot sling for urinary incontinence with mesh.The patient stated that her problems started after that surgery.She then had sling mesh removal in (b)(6) 2018.She has felt much improved since that surgery but needed to have a urethral reconstruction.She was awaiting for that surgery.She has urinary incontinence and has to wear depends daily.Last pap smear was on (b)(6) 2017 with negative/negative.Mammogram was (b)(6) 2018, negative.Denied breast complaints.Assessment and plan of the physician included a well woman examination without gynecological examination.No pap smear needed until (b)(6) 2022.Normal breast examination.Needed screening mammogram in (b)(6) 2019.Urgency incontinence will follow-up at another healthcare facility.Pelvic and perineal pain.Rectal bleeding and was advised to see her gi specialist on (b)(6) 2018.The patient was seen and examined on (b)(6) 2018 for continuing management of prurigo nodularis - excoriated papules and occasionally draining ulcers- on right cheek, right chest, and previous on back, thighs.In the physician's assessment, the question of sweets or another neutrophilic dermatosis.While not present at their appointments, her interim severe swelling could be consistent.Recommend biopsy of new area of rash for definitive diagnosis but she was hesitant, would like to defer today.Reviewed that diagnosis was important (rec biopsy) then treatment options could include oral dapsone, oral colchicine, and other oral immunosuppressants.Scheduled for three upcoming surgeries in the next six weeks, would not recommend starting immunosuppressants until after these procedures.They discussed about prescribing her sulfadiazine and dapsone creams.Risks, benefits, and alternatives reviewed today.Advised to not pick on the lesions on her right cheek.Initiated sulfadiazine 1% cream to open skin two times a day.Ordered today.Initiated dapsone 5% gel to boils two times a day.Ordered today.Silver sulfadiazine 1% external cream; to open skin twice daily dispense: 50 gm.Refill: 5.Dapsone 5% external gel; to boils on skin twice daily dispense: 60 gm; refill: advised for skin culture and sensitivity test with gram.As for the patient's prurigo nodularis, the patient reported boils on her back consistent with prurigo nodularis.Patient will be having surgery on (b)(6) 2018.Biopsy offered, patient declined, plan at follow up in six weeks.Advised to discontinue oral cephalexln for now until after her surgery.Return to clinic in late (b)(6) 2018 or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2018 for a follow up on several issues and to get clearance for dental surgery (root canal).Since her last visit she underwent colonoscopy in seattle for rectal bleeding.She was found to have multiple internal hemorrhoids.She stated that she referred her back to her normal gastroenterologist for follow-up on this.She has also been seeing infectious disease specialist in olympia.She was started on topical dapsone and continued on chlorhexidine washes.She stated that she'll be following up with him after surgery from her slowest in seattle for removal of mesh, which has been the source of ongoing infection.She stated that she was diagnosed with sweet syndrome following multiple tests.She will be following up with specialists in the next week or two.The patient was seen and examined on (b)(6) 2018 for preoperative examination.She'll be seeing her urine gynecologist at virginia mason for removal of infected mesh and rectocele correction.History significant for sweets syndrome, seizure in response to sodium pentothal, fibromyalgia and urinary incontinence.She was currently being followed by gynecology, infectious disease and dermatology.She was currently continuing to experience lower abdominal pain and cramping.She denied any dysuria nor hematuria.She did recently underwent banding of hemorrhoids which was extremely successful.Since then hematochezia or rectal pain was noted.She has no cardiovascular history.She stopped smoking but did continue to use a vaporizer.She was able to complete all of her tasks by herself at home.Ekg in office today was normal.She was advised to get her labs done as previously requested by her surgeon.If needed, they can reorder this when necessary.Physical examination unremarkable.She has argument with her surgeon regarding stopping current medications before the surgery.She was low cardiovascular risk.Advised to avoid sodium pentathol, but otherwise no contraindications.The physician filled out her form for the surgeon.She wondered about home health, advised to discuss with surgeon first the physician was unsure with her recovery and expected limitations.Please see block h10 for b5 continuation.

Manufacturer Narrative

Blocks b5, b7, and h6: patient code and impact code has been updated based on the information received on february 7 and 21, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of january 8, 2018 was chosen as a best estimate based on the date of the mesh removal surgery.Block b5 continuation: the patient was seen and examined on (b)(6) 2019 for prurigo nodularis.She was last seen on (b)(6) 2018, at which time she was provided sulfadiazine 1% cream to be applied twice a day to open skin and dapsone 5% gel to boils twice a day.She was recommended to consider biopsy or other oral immunosuppressants if her skin erosions were not improving.Since the last visit, she saw an infection specialist at virginia mason who recommended that she stop her antibiotics.After a week, her face started to swell, so she restarted the medication about two days ago.She was now taking doxycycline and applying dapsone, the infection specialist also referred her to rheumatology.She had a biopsy on 2004, showing sweet's syndrome.In the physician's assessment, biopsy proven sweet's syndrome by 2004 pathology report.Possibly now rosacea, boils, or sweet's.Recommend she continue cephalexin 500 mg daily and topical dapsone.Discussed the risk of antibiotic resistance with long term antibiotic use.For further improvement, recommend she initiate dapsone 25 mg daily.Usually tolerated well but can cause suppression to the bone marrow.Risks, benefits, and alternatives reviewed.Offered injections today to calm the flare.Patient accepted.Considered tapering down on cephalexin at next visit.The patient was seen and examined in the emergency room on (b)(6) 2019 for an intolerable pain and her pcp cannot help.The patient had a history of irritable bowel syndrome, lupus, and a major abdominal surgery several months ago and presented for an oxycodone refill.Stated that she was allergic to ibuprofen, and she was taking as much tylenol as she can.She got her medications filled regularly by a physician and per edie review, last refill was a week and half ago.She was out of the medication and was having "severe" abdominal pain.Located over this site of her last surgery, no new symptoms including nausea, vomiting, changes in stool nor urination.Stated it was her chronic pain that she needed the medication refill for.Advised the patient that the physician cannot do narcotic refills.She denied any new symptoms or new pain.The patient was seen and examined on (b)(6) 2019 for continued management of prurigo nodularis.In the physician's assessment, the patient had a good response to kenalog injection, well-controlled with prednisone.Discussed that after lesions became under control, the next step was tapering dapsone.Patient was able to stop taking antibiotics since her last visit.Ilk offered today and patient accepted.Continue dapsone 25 mg daily and topical dapsone.Injection of intralesional up to and include seven lesions.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection was given.Return to clinic in six weeks for prurigo nodularis or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2019 for continued management of prurigo nodularis.In the physician's assessment, the patient had much improved with dapsone treatment.Good response to kenalog injection, well-controlled with prednisone.Discussed that after lesions become under control, the next step was tapering dapsone.Ilk offered today and patient accepted.Three spots on right cheek, right chest x 2.Continue dapsone 25 mg oral tab; take 2 tablets (50 mg) by mouth daily.Dispense: 60 tablets; refill: 2.Injection of intralesional up to and include seven lesions.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection was given.Labs ordered include cbc with differential.Comprehensive metabolic panel, and reticulocyte count.Return to clinic in eight weeks for prurigo nodularis or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2019 for check up and would like to discuss medical problems and was told she needed to have knee surgery again.The patient had chronic pelvic pain and neurologic discomfort after a mesh implant became infected and had to be removed.She underwent several surgeries in the last year, and the physician started her on gabapentin for the pain.Overall, she felt much better.The left sided burning pain has resolved.However, she still has right sided pelvic pain.She saw a surgeon again in two weeks.She saw her dermatologist and id for sweet's disease and chronic lesions.These were being injected with steroids and treatment with dapsone.She was seeing ortho locally for chronic knee pain.She was finishing up pt and was set to see the surgeon again soon.In the physician's assessment, the patient needed to continue gabapentin and has been much improved.The patient was requesting to try something else to help with the ongoing right-side pain.Will try low dose amitriptyline.Follow up with surgeon was advised.The patient wanted to avoid chronic opiod if possible, if not controlled the patient could consider pain clinic evaluation.Amitriptyline 25 mg oral tablet, (25 mg) 1 tab(s), oral, once a day (at bedtime) was prescribed for chronic pain.Instructions for pain, #30 tab(s), 3 refill(s).The patient was seen and examined on (b)(6) 2019 for continued management of sweet's syndrome with associated prurigo nodutaris.Since the last visit, she noted that her sweet's syndrome has been flaring for about a week.She developed new lesions on her left cheek and central chest, and her existing lesions have increased in size.The lesions on her left cheek and on her right anterior thigh have been particularly painful.Her lymph nodes have been swollen during this period.She has been taking cephalexin with benefit.She denied any numbness and fatigue associated with her dapsone usage.In the physician's assessment, the patient has been experiencing a flare of her sweet's syndrome for the last week, and noted the development and worsening of lesions on her right thigh, chest, and bilateral cheeks.Upon examination, she has slight swelling around her jaw and excoriated plaques to the bilateral cheeks, right anterior thigh, and chest.Recommended she begin colchicine in addition to continuing her dapsone regimen.For acute treatment of the flare.In her condition, the patient would like to pursue intralesional kenalog injections.Ilk injections offered today and patient accepted.Ilk given was 2 ml (5 mg/ml) for a total of 10 mg.Continue dapsone 25 mg daily and topical dapsone.Colchicine 0.6 mg oral tablet; take 1 tablet (0.6 mg) by mouth two times a day.Dispense: 60 tablets; refill: 2.Triamcinolone acetonide (kenalog-10) 10 mg/ml injection.Injection of intralesional up to and include seven lesions.The patient was advised to return to the clinic in six weeks or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2019 for sweet's syndrome and prurigo nodularis.Since the last visit, she started taking the colchicine 0.6 mg and reported that her sweet's and prurigo nodularis has improved significantly.She had random breakouts last week on her chest, left cheek, and left lip and she reported that these lesions are "flaky" off much quicker.In the physician's assessment, the prurigo nodularis and sweet's syndrome improved on dapsone 25 mg twice a day and colchicine 0.6 mg.Recommend she continue.Risks of medications were reviewed.She will let the physician know if she became fatigued or if she noticed numbness and tingling.The patient was advised to return to the clinic in eight weeks or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2019 for continued management of sweet's syndrome and prurigo nodularis.Since the last visit, she reported that she did not increase her dose of dapsone.She has noticed that the lesion on her left cheek has on gotten worse.She has also noticed a new lesion on her right cheek.She thought that these flare up more with stress.She was having surgery on her left knee this week, which was causing her to be more stressed than usual.No new treatments have been tried.Given she was having surgery this week, the physician recommend that she not change anything with her medications until afterwards.The patient was seen and examined on (b)(6) 2020 for continued management of sweet's syndrome and prurigo nodularis.Since the last visit, the lesions on her right and left cheek have returned.She has noticed that the lesion on her right cheek in particular has become harder.She has also noticed there was a lesion on her chest.She has noticed that when she was stressed it made these lesions worse.No treatments have been tried.Exacerbation factors unknown.The patient had a recent knee surgery that went well.In the physician's assessment, the patient was stable overall.The patient flared a bit with stress (e.G.Recent knee surgery).Tolerating dapsone well, no nausea nor vomiting, shortness of breath, increased fatigue at 50 mg daily.The patient presented today with a worsening lesion on her left and right cheek and her chest.She thought that the lesions flare under stress.Given that ilk has been beneficial in the past, the physician recommend that they do ilk injections today and patient accepted.The patient was advised to return to the clinic in four to six weeks or sooner as needed for acute concerns.The patient was seen and examined on (b)(6) 2020 for follow up on problems due to the mesh and discuss the gabapentin she stopped due to side effects which was giving her breathing problems.Patient was also concerned about her weight loss.The patient has history of chronic pelvic neuropathic pain.She has history of a mesh was which was placed, became infected and has caused ongoing problems.She continued to follow up with her surgeon in seattle.She stated she recently had a follow-up and was advised to follow-up in the next month or two for her one-year checkup.There has been minimal improvement since the surgery.Pain was severe and daily, burning and deep in nature.She was placed on gabapentin for this which was helpful however she did not wish to take this medication anymore.She stated that it caused her respiratory distress as well as dizziness.She has stopped completely and was taking three tablets/day.She also stated that she has a seizure disorder.The physician has not witnessed seizure nor saw neurology notes confirming this.She has had no recent seizure activity.She would like to change to a different seizure medication.She recently had knee surgery with orthopedist.She stated this was healing well.She was currently on a crutch.In the physician's assessment, the patient has not had seizures while on gabapentin.The physician will titrate her off and changed to trileptal as this may help with her neuropathic pain as well.Going to place referral to a neurologist for formal seizure work-up and recommendation.The physician would also like if they could address her neuropathic pain.They did discuss pain clinic as a possibility.She was instructed to call her surgeon for her yearly follow-up.Additional information received on february 7 and 21, 2023.On (b)(6) 2017, patient had pelvic sonographic evaluation for pelvic mesh surgery including 3 dimensional sonographic rendering.On (b)(6) 2017, physical examination showed moderate vaginal atrophy.On (b)(6) 2018, patient was two weeks post mesh removal.She noted some bleeding on her underpads but unsure as to the source of her bleeding.Pelvic exam showed no bleeding from vaginal vault and no appreciable external bleeding from urethra or rectum.Ct abdomen/pelvis with contrast was negative for any acute abnormalities.Urinalysis was also negative for blood.Reevaluation showed her pain was much improved with iv hm, otherwise, vitals remain stable.Patient was advised to take tylenol and aleve for pain control, follow up appointment with pcp or urology in 1 week and ct abdomen and pelvis with iv contrast.It was also reported that the patient was experiencing anxiety disorder.On (b)(6) 2018, there was apparently more mesh that needs to be removed but that will be done in (b)(6) 2018.She was concerned the fever suggests that the mesh needs to come out sooner.She claimed to have cough, denied abdominal pain and dysuria.It was also reported that the patient started keflex.Ct abdomen/pelvis showed only constipation.On (b)(6) 2018, patient reported dyspareunia, the rectal bleeding initially stopped after surgery in (b)(6) 2018 but has returned.On (b)(6) 2019, the patient had surgery for harvest of rectus fascia graft, rectocele repair with perineorrhaphy and autologous fascial sling placement for the treatment of rectocele and stress urinary incontinence.Postoperatively, cystourethroscopy revealed bilateral efflux of urine from her urinary orifices and no other acute findings in the urethra or bladder.She had high - grade posterior wall prolapse, and stress urinary incontinence consistent with intrinsic sphincter deficiency.Postoperatively, she had restored support of her posterior wall.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).Block h6: patient code e2401 captures the reportable event of unknown injury patient code e172001 captures the reportable event of abscess.Patient code e230901 captures the reportable event of calcification.Patient code e0701 captures the reportable event of respiratory distress.Patient code e2330 captures the reportable event of pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e2339 captures the reportable event of ulcer.Patient code e1906 captures the reportable event of infection.Patient code e2326 captures the reportable event of inflammation.Patient code e1710 captures the reportable event of lesion.Patient code e0122 captures the reportable event of movement disorder.Patient code e1705 captures the reportable event of burning sensation.Patient code e2312 captures the reportable event of fatigue.Patient code e230101 captures the reportable event of fever.Patient code e1715 captures the reportable event of scar tissue.Patient code e2315 captures the reportable event of fluid discharge.Patient code e0123 captures the reportable event of nerve damage.Patient codee2338 captures the reportable event of swelling.Patient code e0506 captures the reportable event of hemorrhage.Patient code e2015 captures the reportable event of atrophy.Patient code e1405 captures the reportable event of dyspareunia.Impact code f2303 captures the reportable event of medication required.Impact code f1202 captures the reportable event of disability.Impact code f1901 captures the reportable event of additional surgery.Impact code f1903 captures the reportable event of device explantation.Impact code f1903 captures the reportable event of mesh removal.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks h6 and h10 (reportable codes) have been corrected based on medical safety review on november 16, 2022.Block h6: patient code e172001 captures the reportable event of abscess.Patient code e2330 captures the reportable event of pain.Patient code e1002 captures the reportable event of abdominal pain.Patient code e2339 captures the reportable event of ulcer.Patient code e1906 captures the reportable event of infection.Patient code e2326 captures the reportable event of inflammation.Patient code e1710 captures the reportable event of lesion.Patient code e1705 captures the reportable event of burning sensation.Patient code e2312 captures the reportable event of fatigue.Patient code e230101 captures the reportable event of fever.Patient code e1715 captures the reportable event of scar tissue.Patient code e2315 captures the reportable event of fluid discharge.Patient code e0123 captures the reportable event of nerve damage.Patient codee2338 captures the reportable event of swelling.Patient code e0506 captures the reportable event of hemorrhage.Impact code f2303 captures the reportable event of medication required.Impact code f1202 captures the reportable event of disability.Impact code f1901 captures the reportable event of additional surgery.Impact code f1903 captures the reportable event of device explantation.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block 11 section e.Initial reporter has been corrected.

• Brand Name: OBTRYX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13595319
• MDR Text Key: 288116040
• Report Number: 3005099803-2022-00871
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: 0ML7113003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 08/08/2022; 10/11/2022; 11/16/2022; 02/07/2023
• Supplement Dates FDA Received: 09/01/2022; 11/10/2022; 12/15/2022; 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female