|
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2018: (b)(6).[ni] [not indicated].Face sheet.Not employed.Medicaid.(b)(6) 2018: (b)(6) memorial hospital.(b)(6).Pre-anesthesia evaluation.Procedure history includes cystoscopic lithotripsy of ureteric calculus, cholecystectomy, total hysterectomy.Education: 9th grade.Current every day smoker.Tobacco use per day, 20.Started at age 14 years.Weight 290.35 pounds.Asa class iii.(b)(6) 2018: (b)(6) memorial hospital.(b)(6).History and physical.Returned to my office because of large mid-abdominal wall hernia.Was evaluated by (b)(6) 2018, suggested repair of hernia.At that time, had other medical problems of breast carcinoma.She postponed surgery and breast carcinoma was cared for.Returns for treatment of hernia.History hypertensive cardiovascular disease, transient ischemic episode, chronic back pain, breast carcinoma, vague abdominal pain, obesity.Has had multiple surgical procedures, 2017 cholecystectomy, hysterectomy, excision of ducal carcinoma in situ from left breast, sentinel node biopsy.Nodes negative.Heavy smoker, attempting to stop.Large bulge in mid-abdomen.Moderately obese, abdomen soft, liver and spleen not enlarged, ventral hernia in mid-abdomen from supraumbilical area toward infraumbilical area, partially reducible, surgical scars from hysterectomy, no costovertebral angle tenderness, good bowel sounds, inguinal areas normal.Scheduled for repair of ventral hernia.Implant procedure: repair of a large ventral hernia, mid abdomen using synecor mesh.Implant: gore® synecor® plus biomaterial [gkfc12/16396912, 12 cm diameter].Implant date: (b)(6) 2018 (hospitalization (b)(6) 2018).(b)(6) 2018: (b)(6) memorial hospital.(b)(6).Operative report.Preoperative diagnosis: large ventral hernia, mid abdomen.Postoperative diagnosis: large ventral hernia, mid abdomen.Procedure: repair of a large ventral hernia, mid abdomen using synecor mesh.Anesthesia: general.Description of procedure: ¿this 55-year-old female patient was brought to the operating room placed in supine position.General anesthesia was given.A foley catheter was introduced.Abdomen was prepared and draped in the usual fashion.A midline incision was made in the mid abdomen.The upper part of the previous hysterectomy scar was excised.Skin and subcutaneous tissue were incised.Flaps were raised to either side.Large hernia defect was noted.Extending from the mid portion midway between the umbilicus to the pubic symphysis to midway between the xiphi sternum to the umbilicus.The hernia sac was completely separated from the subcutaneous tissue, and fascia was identified on either side.Subsequently, the sac opened.It was noted plenty of adhesions between this inner part of the sac and the omentum.This was slowly lysed, and small bowel was also seen in the sac.This was reduced back into the peritoneal cavity.The sac was excised.A quite large defect was noted in the area.After examining the abdominal viscera and also obtaining hemostasis, the decision was made to place a synecor mesh.I have placed a synecor mesh with the shiny surface was placed toward the peritoneal surface and this was attached to the fascia and the peritoneum and posterior rectus sheath with interrupted sutures of 2-0 ethibond sutures.After completion of the same, i have placed a continuous 2-0 vicryl suture to prevent any herniation through the defect.Following this, the fascia approximated over the mesh with #1 prolene continuous sutures.Prior to closing the fascia completely, i have instilled tissel [sic] fibrin glue over the mesh, so the fascia will adhere to the mesh completely, and the defect was completely closed with prolene.Following this, the subcutaneous plane tacked down to the fascia.Deeper portion of the subcutaneous plane tacked down to the fascia with #1 vicryl interrupted sutures.Subcutaneous plane approximated with 2-0 plain gut interrupted sutures.Skin approximated with skin clips.Dressing applied.She received a gram of ancef prior to the procedure.She was transferred to recovery room in good condition.¿ (b)(6) 2018: (b)(6) memorial hospital.Adonia c.Guidry, rn.Implant record.Description: gore synecor mesh biomaterial 12 cm diameter circle gkfc12.Quantity 1.Serial number (b)(6).Lot number gkfc12.Load number n/a.Manufacturer w.L.Gore, inc.Catalog # gkfc12.Size 12 cm.Expiration date 4/3/20.Human readable n/a.Manufactured date n/a.Implanted/explanted date (b)(6) 2018.Manufacturer model number n/a.Mr classification unknown.Udi n/a.Procedure hernia repair ventral (none).Implanted by (b)(6).Usage data implant/explant site mid-abdomen.The records confirm a gore® synecor® plus biomaterial (gkfc12/16396912) was implanted during the procedure.Relevant medical information: (b)(6) 2018: (b)(6) memorial hospital.(b)(6).Pathology report.Accession no: s-18-021991.Ordering provider: (b)(6).Final diagnosis: abdomen, ventral hernia repair: lobulated fibroadipose and serosal tissue consistent with ventral hernia sac / sac contents.Code 4.Specimen description: hernia sac.Clinical information: pre-operative diagnosis: ventral hernia of mid abdomen.Gross description: 21991.(b)(6) hernia sac.Labeled on the container with the patient¿s name ¿ (b)(6), hernia sac 21991¿.The specimen is received in formalin and consists of multiple irregular and saccular pieces of tan-pink, wrinkled, membranous soft tissue measuring 1.0 x 9.0 x 3.8 cm in aggregate.The specimen is serially sectioned and no discrete lesions are identified.Representative sections are submitted in a single cassette labeled 21991 #1a, x-f-1.Microscopic description: microscopic examination performed.Please see diagnosis.(b)(6) 2018: (b)(6) memorial hospital.(b)(6).Discharge summary.Brought in for repair of large mid-abdominal hernia.Had exploration of mid abdomen.Has large hernia defect in mid abdomen with incarcerated omentum and known incarcerated small bowel.Plenty of adhesions also noted in hernia sac.Underwent repair (b)(6) 2018 with synecor mesh.Did well postoperatively.By evening, when nurse went to discharge patient, patient felt she might not be able to manage at home during night because of pain, preferred to day overnight.Kept and observed.Discharged on analgesics.Advised to return to my office for follow-up.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Emergency room visit.Presents with fever and chills.Onset 1 day ago.Abdominal pain and on surgical wound, had hernia surgery 3 weeks ago.Temperature 99.9 degrees.Abdomen soft, non-distended, normal bowel sounds, no organomegaly, tenderness moderate, periumbilical, wound, oozing purulent fluid.Lactic acid 2.2, white blood count 11.01.Abdominal wall abscess at site of surgical wound.Consult (b)(6).(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Radiology ¿ ct abdomen.13 x 6 cm collection within subcutaneous fat of anterior abdominal wall.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).History and physical.Reported to emergency room because of pain and swelling of lower abdomen with fever and chills since this morning.Initial temperature 98.96 degrees.Heart rate rapid, rest of vital signs normal.Had repair of large ventral hernia of mid abdomen using synecor.I had seen patient in my office, doing well.At present, developed pain in lower abdomen at site of lower part of incision and also redness and tenderness.Heavy smoker.Abdomen soft, tenderness in lower part of previous surgical incision in mid abdomen, palpable mid abdominal hernia repair, good bowel sounds, inguinal area normal.White cell count 11,000, lactic acid 2.2.Impression large seroma of abdominal wall.Since has low-grade temperature and redness of area, elevated white cell count with elevated lactic acid level, will explore area, drain seroma, get cultures.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Operative report.Preoperative diagnosis: infected seroma of the subcutaneous plane of the lower abdominal wall.Postoperative diagnosis: seroma of the lower abdominal wall.Procedure: incision and drainage of seroma of the lower abdominal wall.Description of procedure.¿this 55-year-old female patient was placed on the emergency room table.Abdomen was prepared and draped in the usual fashion.I injected the 1% xylocaine anesthesia in the lower part of the surgical scar.Subsequently, the incision was made through the scar, about a 3 cm incision was made.The incision was deepened to the deeper portion of the subcutaneous plane until clear seroma fluid was drained out, 400 cc of seroma fluid was drained.After completion of the procedure, the wound dressing was applied.The wound was also irrigated with betadine prior to applying the dressing.Dressing applied.She tolerated the procedure well.She was subsequently admitted to the hospital.She will be placed on iv antibiotic and we will perform wound care periodically.¿ (b)(6) 2019: (b)(6) memorial hospital.[ni].Lab.Anaerobic culture, abscess, abdomen: no growth of anaerobes.Wound culture, abscess, abdomen: many staphylococcus aureus (methicillin-sensitive).Blood culture (16:25): at 5 days, no growth.Blood culture (16:15): at 5 days, no growth.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Pathology report.Accession #: s-19-000209.Final diagnosis: abdominal wall wound, debridement: skin and adipose tissue with extensive fat necrosis, fibrosis, acute and chronic inflammation, focal granulation tissue changes and focal oil cyst formation consistent with wound debridement.Code 6, 7.Specimen description: debridement abdominal wall wound.Clinical information: preoperative diagnosis: seroma abd wall.Gross description: 209, (b)(6), wound drainage abdominal wall.Labeled on the container with the patient¿s name, debridement specimen wound abdominal wall, (b)(6), 209.Received in formalin are unoriented pieces of skin and soft tissue measuring 3.0 x 2.0 x 0.6 cm.The specimen is serially sectioned to reveal a yellow brown cut surface.Representative sections are submitted in a single cassette labeled 209-1a.Cassette key: x-f-1.Microscopic description: microscopic examination performed.Please see diagnosis.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Pre-anesthesia evaluation.Asa class iii.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Operative report.Preoperative diagnosis: infected seroma of the mid abdominal wall.Postoperative diagnosis: infected seroma of the mid abdominal wall.Procedure: drainage of the seroma of the mid abdominal wall and placement of a drainage catheter.Anesthesia: local mac.Description of procedure: ¿this is a 55-year-old female patient who originally had drainage of her seroma done in the emergency room on (b)(6) 2019.Patient had a ventral hernia repair of the mid-abdomen done using synecor mesh.Two weeks back reported to the emergency room because of pain and swelling.The patient already had a cat scan at another time and had drained the seroma.At present, since patient continued to collect the seroma, i felt the patient would benefit from further drainage and placement of a catheter to drain the seroma.Hence, she was brought to the operating room, placed in supine position.Iv sedation was given.1% xylocaine anesthesia was infiltrated in the lower part of the incision already opened in the emergency room.The skin edges were freshened, the wound explored with a finger.Entered the deeper portion of the wound, a large amount of purulent fluid appears like infected seroma was drained out.This was suctioned out.Following this, the cavity was thoroughly irrigated with warm saline.Hemostasis was obtained with diathermy of the skin and subcutaneous tissue areas and a jackson-pratt drain was introduced into the left lower abdomen entering into the seroma cavity.Following this, the drains were anchored to the skin and subcutaneous tissue with 2-0 silk suture, and the small wound made to drain the seroma was closed in layers.The subcutaneous plane approximated with 2-0 chromic interrupted sutures, skin approximated with 3-0 nylon interrupted sutures on the area.I have also placed dermabond to the incision site to seal off the incision site, and dressing applied to both areas.She was transferred to her room in good condition.¿ (b)(6) 2019: (b)(6) hospital.[ni].Lab.Wound culture, abscess, abdomen: moderate staphylococcus aureus (methicillin-sensitive).Anaerobic culture, abscess, abdomen: no growth of anaerobes.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Discharge summary.Admitted (b)(6) 2019 because of pain and swelling of abdomen.Underwent large ventral hernia repair of mid abdomen using synecor mesh.Mesh placed under fascia.I completely closed dead space between mesh and fascia using tisseel fibrin glue.Unfortunately, patient developed a seroma.I am not sure seroma is from site of mesh or just superficial to that in subcutaneous plane.Ct scan has shown subcutaneous fluid collection.I noticed large seroma.Seroma drained under local anesthesia in emergency room.Fluid appeared very clear.I sent for culture.Culture showed staphylococcus aureus methicillin-resistant in fluid.Empirically placed on clindamycin and zosyn.Once culture report available, i canceled zosyn and continued clindamycin, bactrim added.Drainage diminished significantly (b)(6) 2019.I have taken patient back to operating room and drained seroma further.I irrigated area and jackson-pratt drain introduced.The small wound, which was opened during emergency room visit, was closed, and hopefully drainage system will drain all serum fluid and will continue antibiotics.I will be discharging her on medication including bactrim ds and clindamycin.I will follow the patient through my office.(b)(6) 2019: oncologics.(b)(6).Office notes.Intraductal carcinoma in situ of left breast (b)(6) 2018.Arising from 3:00 position, grade 3 with comedonecrosis, ptisn0(sn), close inferior margin, 1 mm, er/pr negative.Treatment: stereotactic biopsy of left breast (b)(6) 2018.Lumpectomy and sentinel lymph node biopsy (b)(6) 2018.Left breast seroma drainage (b)(6) 2018.Radiation therapy with 6040 cgy in 33 fractions to left breast, completed (b)(6) 2018.Here for routine follow up.Now 6 months post completion of radiation therapy.Had a couple surgeries in interim, hernia, hematoma evacuation subsequent to repair.History includes diabetes.Surgical history includes cholecystectomy, cystoscopic lithotripsy of ureteric calculus, colonoscopy (b)(6) 2015, excision large intestine (b)(6) 2015.Current every day smoker 1 pack per day for 30 years (30 pack-years).Complains of weight loss of more than 16 pounds.Weight 298 pounds.Caucasian.Generally doing well 6 months post completion of therapy.Offered reassurance that pain will continue to improve and pain medication does not necessarily help neuropathic pain in this scenario.I offered trental and vitamin e to hopefully help with healing process.See back in 6 months.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Radiology ¿ ultrasound abdomen limited.Indication palpable lump, scar.Target abdominal wall, there is a tubular or linear soft tissue echogenicity with diameter 1.2 cm and is non-specific, which could represent scar.Infection or hernia are alternative considerations.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Emergency room visit.Complains of abdominal wall abscess starting 1 week prior to admission.Pain, redness, drainage.Abdominal pain, mild, periumbilical, acute.Open abscess with mild drainage from this area.Abdomen soft, abscess that is opened and draining below umbilicus, good bowel sounds, mild tenderness, negative for guarding, rebound, organomegaly.Discharged on clindamycin.Follow up with primary care provider in 3-4 days.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Radiology ¿ ct abdomen pelvis.Redemonstrated inflammatory fat stranding of midline infraumbilical subcutaneous tissues.Overall appearance of decreased severity in interval.More organized fluid component now measures approximately 11 x 2.8 x 3.4 cm (previously 16.4 x 6.4 x 8.7 cm).No suggestion of acute inflammatory alteration of immediately subjacent intraperitoneal structures.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).History and physical.Reported to my office because of drainage from abdominal wall.Drainage continued, hence i suggested probably exploring the sinus and excising the sinus and possibly draining and placing another drain.She understands the possibility the synecor mesh got infected and eventually has to be removed.Has chronic back pain and breathing problems, takes albuterol.Smokes.Abdomen soft, liver and spleen not enlarged, previous surgical scar, abdominal wall sinus draining, inflammatory changes noted, no recurrence of hernia, costovertebral angle area normal.Scheduled for exploration of sinus by sinogram and fully excising sinus and if necessary, place drain.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Pre-anesthesia evaluation.Asa class ii.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Operative report.Preoperative diagnosis: abdominal wall sinus.Postop diagnosis: abdominal wall sinus.Procedure: exploration of the abdominal wall sinus and excision of the sinus.Anesthesia: general.Description of procedure: ¿this 56-year-old female patient was brought to the operating room, placed in supine position.General anesthesia was given.Abdomen was prepared and draped in usual fashion.Initially, culture specimens were obtained from the sinus tract and following this, a #12 foley catheter was introduced into the sinus tract and gastrografin was injected.It was noted it is entering into the cavity and there was no extension in to the abdominal cavity.Following this it was removed.By elliptical incision, sinus tract was excised.It was extending all the way down to the fascia.At the fascia level, several prolene sutures were noted.These were removed and the sinus tract ended in that area.No extension into the synecor mesh noted.A small piece of the synecor mesh of course was removed along with the sutures.Area thoroughly irrigated with warm saline.Hemostasis was obtained.Subsequently, a jackson-pratt drain was introduced through the left lateral abdominal wall into the depth of the wound and the fascia, which was partially resected, was reapproximated with 0 vicryl interrupted sutures, subcutaneous tissue 0 vicryl sutures, and the skin approximated with skin clips.Drain affixed to the skin with 2-0 silk suture.Dressing applied.She tolerated the procedure well.She received a gram of ancef prior to the procedure.¿ (b)(6) 2019: (b)(6) hospital.[ni].Lab.Anaerobic culture, drainage, abdomen: no growth of anaerobes.Wound culture, drainage, abdomen: moderate staphylococcus aureus, methicillin-sensitive.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Pathology report.Accession: s-19-020552.Ordering provider: (b)(6).Final diagnosis: abdominal wall sinus specimen, excision: sections of skin and subcutaneous fibroadipose tissue with changes suggestive of organizing abscess.Code 7, 4.Specimen description: abdominal wall sinus specimen.Clinical information: pre-operative diagnosis: abdominal wall sinus.Gross description: 20552, (b)(6), abdominal wall sinus specimen.Labeled on the container ¿abdominal wall sinus specimen, 20552.¿ received in formalin are multiple unoriented pieces of skin, soft tissue and blue surgical suture.The specimen measures 5.7 x 5.0 x up to 2.5 cm.The skin is wrinkled, pale gray tan and has an ulcer measuring 1.5 x 0.5 x 1.7 cm in depth.The specimen is serially sectioned to reveal a light yellow to yellow gray cut surface.Representative sections are submitted in a single cassette labeled 20552-1a.Cassette key: x-f-1.Microscopic description: microscopic examination performed.Please see diagnosis.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Emergency room visit.Abdominal pain increased with position change.Obese white femal status post post-surgical drainage of abdominal abscess 2 weeks ago.Prior to arrival was lying in bed with jackson-pratt drain draining from abdomen.Sat up and positive abdominal pressure apparently pushed out part of internal structure of drain causing localized abdominal pain.Surgeon notified, plans to see in clinic tomorrow.In meantime will give dilaudid.Exam notes morbidly obese, abdomen soft, normal bowel sounds, obese abdomen with jackson-pratt drain just to left of umbilicus draining serosanguineous fluid.Part of internal structure of drain, a triangular white plastic drain approximately twice with the tubing has been pushed out approximately 2 cm.No bleeding.Discharged home.(b)(6) 2019: (b)(6) memorial hospital.[ni].Lab.Hemoglobin a1c 7.9 h (4.5-6.2), estimated average glucose 180.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Emergency room visit.Seen (b)(6) 2019 for surgical drain that had been partially displaced.Seen following day in dr (b)(6) office for removal of drain.Since then, wound has developed erythema and tenderness with serous drainage from where drain was.Erythema extends periumbilical with diameter 17 cm horizontally and 11 cm vertically.Nausea.Risk factors smoking and obesity.Doxycycline completed.Abdominal wall erythema and tenderness with 1 cm postsurgical drain site having been removed 3 days ago, now mild amount of serous drainage from site.Abdomen soft, non-tender, normal bowel sounds.Abdominal wall abscess.Admit.(b)(6) 2019: (b)(6) memorial hospital.[ni].Lab.Wound culture, drainage, abdomen: many staphylococcus aureus (methicillin-sensitive).(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Radiology ¿ ct abdomen/pelvis.Involving anterior abdominal wall in periumbilical region, there is a low-density fluid collection with several locules of air suggestive of abscess.Within region of known laparotomy incision.Largest fluid collection measures 5.5 x 4.3 cm.Appears to be autolysis with umbilicus.Involvement of peritoneal fascia without evidence for involvement of peritoneal cavity.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).History and physical.Presents to emergency department with redness and drainage to abdominal wall.Apparently underwent surgery a couple weeks ago and had drain placed.Placed on antibiotics for the previous abscesses.Drain removed a few days ago.Completed antibiotics a few days ago.Site more red and painful.Pain 7/10 and constant.Previously grow methicillin-sensitive staphylococcus aureus from wound.Ct scan does show evidence of another abscess.Surgery will be consulted.Weight 137.1 kg, bmi 49.16.Abdomen soft, tenderness around umbilicus, non-distended, normal bowel sounds, no organomegaly, obese.Abdominal wall abscess, tobacco user.Admit to inpatient, intravenous antibiotics.(b)(6) 2019: (b)(6) memorial hospital.[ni].Lab.Anaerobic culture, drainage, abdomen: no growth of anaerobes.Wound culture, drainage, abdomen: moderate staphylococcus aureus (methicillin-sensitive).(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Consultation.Patient well-known to me.Had undergone ventral hernia repair of mid abdomen with synecor mesh (b)(6) 2018.Had long-standing hernia of mid-abdomen.Immediate postoperative period was uneventful.Had seroma, drained with closed drainage system.Subsequently doing well, then within last month, developed infection of abdominal wall, seen in emergency room.Subsequently reported to my office and evaluated, and i explored the small sinus tract in abdominal wall, it was excised and drain placed.Drain removed subsequently.At present, has come with recurrence of abdominal wall infection.Seen in emergency room (b)(6) 2019.Emergency room physician obtained ct abdomen, showed phlegmonous changes and abscess of laparotomy incision with involvement of anterior abdominal wall.No evidence of extension of the peritoneal cavity, and abdominal wall has fluid collection with multiple locules of abscesses.Was admitted by hospitalist and placed on clindamycin.I was asked to evaluate patient today.Has multiple medical problems including chronic back pain, respiratory problems.She is diabetic and while in hospital 11/13/19, i noticed elevated blood sugar.I advised her to see dr.Scott bergeaux regarding this to work up.At this time, on admission through emergency room, hemoglobin a1c was 7.9 and blood glucose 193.Definitely needs control of diabetes.It will be very difficult to control infection if diabetes is not managed.At present, i do not see any medications given for diabetes.Patient is a heavy smoker.Moderately obese.Abdomen soft, surgical wound, new opening on upper part of mid-abdomen, moderate drainage, previous drain site completely healed, sinus tract incision site also healed, liver and spleen not enlarged, minimal tenderness of area of cellulitis around open draining site, lower abdomen normal, no costovertebral angle tenderness, good bowel sounds, no inguinal lymphadenopathy.Infection of abdominal wall with abscess, status post incisional hernia repair of mid-abdominal wall using synecor mesh.Needs exploration of abdominal wall, drainage of abscess, possibly removing mesh and repairing hernial defect without mesh.She understands i will be retiring at end of december.She agreed to stop smoking form now on.Otherwise, she understands there is no way we could get her wound healed.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Pre-anesthesia evaluation.Asa class iii.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Operative report.Preoperative diagnosis: abscess, abdominal wall with possible infected synecor mesh.Postoperative diagnosis: abdominal wall abscess.Procedure: exploration anterior abdominal wall and drainage of abdominal wall abscess.Description of procedure: ¿this 56-year-old female patient was brought to the operating room and placed in the supine position.General anesthesia was given.The patient has a foley catheter.A nasogastric tube was introduced.The abdomen was prepped and draped in the usual fashion.Initially, the patient had an inflamed area in the upper portion of the previous incision site with drainage.By an elliptical incision the draining area was also excised.An incision was made through the previous surgical scar.The subcutaneous tissue opened all the way to the fascia.Thin purulent fluid was identified.This was suctioned out, irrigated out.Moderate bleeding was noted because of the inflammatory changes and also it was extremely difficult to separate the tissues safely to identify the synecor mesh.After a few attempts, i decided not to perform the same.The wound thoroughly irrigated with normal saline and subsequently, the deeper part of the subcutaneous tissue reapproximated with #1 vicryl interrupted sutures.Following this, superficial portion packed with the sterile gauze and the skin approximated with 2-0 nylon interrupted sutures.The tip of the gauze was brought out through the lower part of the incision.In fact, i used kerlix to pack the area.After completion of the procedure, a dressing applied.She tolerated the procedure well.She will be receiving antibiotics, including clindamycin and oxacillin.I have obtained fresh cultures also.The patient may have to be on antibiotics for long-term.Once the inflammatory changes are completely resolved, hopefully, we will be able to see the mesh.If not, it needs to be removed at a later date after the inflammatory changes are under control.Once i retire, i will definitely refer the patient to one of my colleagues to continue to follow her up.She and her boyfriend know that also.I explained to them even prior to surgery, and i will explain the same following surgery also.Also, she needs to have her diabetes mellitus well-controlled and needs to stop the smoking.¿ (b)(6) 2019: (b)(6) memorial hospital.[ni].Lab.Wound culture, drainage, abdomen: moderate staphylococcus aureus (methicillin-sensitive).Anaerobic culture, abscess, abdomen: no growth of anaerobes.(b)(6) 2019: (b)(6) memorial hospital.(b)(6).Discharge summary.Presented to emergency department with pain and redness with drainage on abdominal wall.Recent surgery, had drain placed.Placed on antibiotics for previous abscesses.Drain removed a few days prior to presentation.Site more red and painful.Repeat ct scan shows evidence of abscess.Surgery was consulted.Incision and debridement of area.Wound cultures positive for methicillin-sensitive staphylococcus aureus.Due to extensive area of abscess, will be discharged on intravenous oxacillin with briova rx to aid with infusion.Prescription for clindamycin for 15 days.Will also consult home health to follow along.Patient diagnosed with diabetes during this admit.Hemoglobin a1c 7.9.Started on metformin.Follow up in clinic in 1 month.Follow up with dr (b)(6) outpatient.Abdomen soft, non-tender, non-distended, normal bowel sounds.(b)(6) 2020: (b)(6) memorial hospital.[ni].Lab.Hemoglobin a1c 6.2 (4.5-6.2), estimated average glucose 131.(b)(6) 2020: [facility ni].(b)(6).Office notes.Abdominal incision red, painful, drainage.Chills, recent abdominal wall abscess, seen in clinic (b)(6) 2020, given prescription for bactrim ds for 1 week, draining pus and blood.History includes diabetes, obesity.Weight 136 kg, bmi 47.06.Abdomen soft, non-tender, normal distension, positive bowel sounds.Abdominal wall purulent drainage, abscess on superior aspect of previous surgical incision.Prescription for clindamycin for 10 days.Wound care discussed.Consult dr (b)(6).See attachment for h10/11 continuation.
|
|
H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repairs of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection is suspected, dissection of involved tissues should be considered.If infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.¿these may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
