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BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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| Model Number M0068317100 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Fatigue (1849); Fever (1858); Fistula (1862); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Muscle Weakness (1967); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Chills (2191); Dizziness (2194); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); No Code Available (3191); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)
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| Event Date 08/19/2009 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2009, implant date, as no event date was reported.This event was reported by the patient's legal representation.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a pinnacle pelvic floor repair mesh was implanted into the patient during a procedure performed on (b)(6) 2009 for the treatment of pelvic organ prolapse, cystocele, rectocele, and enterocele.As reported by the patient's attorney, sometime after the procedure, the patient began experiencing severe and debilitating pain, infections and dyspareunia.The patient has experienced mental and physical pain and suffering, including erosion, mesh contraction, fistula, inflammation, scar tissue, organ perforation, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, and chronic pelvic pain, and has sustained permanent injury.Subsequently, the patient has been forced to undergo extensive medical treatment including, but not limited to, operations to locate and remove mesh on (b)(6) 2014, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.Reportedly, the patient continues to suffer serious bodily injury and harm.She continues to receive medical treatment and is anticipated to undergo further medical treatment and surgeries to remove more mesh.This report was originally submitted via asr.Report identification number: (b)(4).Submission period: september 1, 2015 to october 31, 2015.Asr exemption number: e2013036.(b)(4).
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Event Description
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It was reported to boston scientific corporation that a pinnacle pelvic floor repair mesh was implanted into the patient during a procedure performed on (b)(6), 2009 for the treatment of pelvic organ prolapse, cystocele, rectocele, and enterocele.As reported by the patient's attorney, sometime after the procedure, the patient began experiencing severe and debilitating pain, infections and dyspareunia.The patient has experienced mental and physical pain and suffering, including erosion, mesh contraction, fistula, inflammation, scar tissue, organ perforation, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, and chronic pelvic pain, and has sustained permanent injury.Subsequently, the patient has been forced to undergo extensive medical treatment including, but not limited to, operations to locate and remove mesh on (b)(6), 2014, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.Reportedly, the patient continues to suffer serious bodily injury and harm.She continues to receive medical treatment and is anticipated to undergo further medical treatment and surgeries to remove more mesh.This report was originally submitted via asr.Report identification number: (b)(6) submission period: september 1, 2015 to october 31, 2015.Asr exemption number: e2013036.Pro code: otp.*additional information received on january 14, 2022: the patient was implanted with a pinnacle pelvic floor repair mesh during an anterior/apical compartment, sacrospinous ligament fixation and cystoscopy procedure performed on (b)(6), 2009.After the procedure, the patient experienced vaginal burning, incomplete bladder emptying and uti for which she initially took keflex on (b)(6), 2009.However, this was changed to levaquin 500mg daily for seven days when urine culture sensitivities returned on (b)(6), 2009 (urine culture taken on (b)(6), 2009 showed pseudomonas 50-100k).During her last visit at that time, a urine culture was sent and returned no growth.Secondary to her high pvrs, the patient was kept on macrobid suppression.On (b)(6), 2009, the patient reported the following: 1.Feeling fatigued and occasionally lightheaded which was new since her last visit 2.Burning sensation resolved.3.Shooting sharp pains in the vagina and subsequent discharge (the pain is very short lived and resolves on its own.This occurs 3-4 times per day and had been going on for a month.The pain rates a 7-8/10 when it occurs).4.Focal pruritus on her physical exam on that day, it was noted on vagina a 1-2cm granulation tissue at incision line along mid anterior wall that was tender to palpation.No tenderness over mesh at arcus and no mesh erosion was noted.Silver nitrate was applied to the granulation tissue.On apex, the cuff was noted well healed.The patient has pain at the vaginal apex on each side where the mesh anchors into the sacrospinous ligament.Assessments on that time included: 1.Vaginal vault prolapse after hysterectomy - resolved 2.Cystocele, midline, asymptomatic, mostly periurethral 3.Enterocele - resolved 4.Rectocele - resolved 5.Chronic abdominal pain - with a history of multiple laparotomies and bowel resections for sbo (small bowel obstruction), known severe adhesive disease 6.Urgency of urination - resolved off vesicare 7.Urge incontinence - resolved off vesicare 8.Nocturia - resolved off vesicare 9.Levator muscle weakness - mild 10.Atrophic vaginitis - mild 11.Detrusor overactivity 12.Decreased bladder capacity, normal compliance up to 250cc, no prolapse, reduced usi 13.Incomplete bladder emptying postoperatively with pvr 210 cc - asymptomatic 14.Granulation tissue, treated with silver nitrate 15.Vaginal shooting pain, may be due to mesh insertion at ssl based on the exam, or granulation tissue as she had pain with palpation of this site and described discharge immediately after the pain.Plans noted included: 1.The physician had a discussion with the patient regarding possible neuropathic origin of her pain if the mesh insertion point entrapped a nerve and the possibility of using lyrica to help with neuropathic pain.The patient also has history of fibromyalgia and this may help with her fibromyalgia pain.The patient was explained the possible side effects of the medication including sedation, and suicidality and counseled to stop the medication if either if the sedation becomes bothersome or she develops suicidality.A patient handout regarding drug information on lyrica was also given.Lyrica 100mg three times a day was started.2.Patient to follow-up in 3-4 weeks on her pain symptoms.Possible options were discussed if the pain does not resolve including cutting the mesh arms, though her prolapse may recur.Anesthetic and steroids injection to the sacrospinous ligament could also be considered.3.The patient was to continue antibiotic suppression if urinary retention persisted.If not worsening, the patient will be evaluated further if symptomatic and bothersome.On (b)(6) 2009, the patient reported that she self-discontinued lyrica as it made her excessively sleepy for two days after the first dose.She had no additional complaints at that time and felt well in general.No more incidence of uti since she had been on macrobid.Lightheadedness, burning sensation, vaginal pain and focal pruritis resolved.Plans at that time included: 1.High pvr continue on prophylactic macrobid for suppression of uti.Refill for macrobid given.2.Vaginal pain resolved.3.Return to clinic in 1 year for follow up visit.On (b)(6) 2012, the patient complained of urinary frequency, urgency and minor leaking uui (urge urinary incontinence) for a month.She had mild dysuria at that time.She suspected that she had a uti and would like to be tested.On exam, some mild recurrent prolapse was noted that was asymptomatic.Plans noted during the visit: 1, urine culture sent, to contact patient with the results.2.Patient to continue routine flu with pcp and cardiologist tor health care maintenance.3, reassured patient regarding normal pelvic exam with good vaginal support and normal bladder emptying.4.Can consider restarting vesicare if urine culture returns negative.On (b)(6), 2012, the patient reported the following: sharp pain that is worse when walking or moving and is better when lying down; pain that lasts for seconds and hurts so bad that it makes her stop walking; heaviness in lower stomach; still having urgency, frequency, nocturia and uui refractory vesicare 5mg; worse symptoms; and fecal incontinence.On physical exam, the patient had tenderness to palpation over the proximal ant wall near mesh arms that insert into la near ischial spines and apically on each lateral fornix that reproduces the pain she feels vaginally and on her left side.Assessments at that time included incomplete bladder emptying postoperatively - asymptomatic, elevated pvr; and pelvic pain radiating to the left leg when walking.The pain seemed to localize the mesh.The patient had postoperative pain that resolved.No change in the position of the mesh on exam.Plan: 1.The physician discussed options of 1) observation and pain management; 2) trial of trigger point injections into obturators and possibly pudendal block; 3) excision of vaginal mesh and or obturator arms.The patient preferred to try a local block.2.Urine sent for culture.To notify the patient if uti.3.Follow-up in 2 weeks for trigger point injections.4.Repeat pvr at f/u appt and if normal, consider increasing vesicare to 10 mg.On (b)(6), 2012, the patient presented for local injection, trigger point at obturator internus muscles near ischial spine and pudendal nerve block at insertion of the apical arm to the ssl.The patient reported pain relief upon injection on the left side.Plan at that time included: 1.Patient to monitor for further improvement at home.If the injection does not resolve or improve the pain, she was discussed about having a surgery.However, she said she would rather live with the pain than have to return to the or for mesh excision.2.Follow up in 2-3 weeks.3.If the retention persists, repeat pvr at follow up appointment.On (b)(6), 2012, the presented for a follow-up visit and reported that had completely resolved.Assessment at that time noted resolved postoperative incomplete bladder emptying, pelvic pain radiating to l leg when walks, and pudendal neuralgia.On (b)(6), 2014, the patient presented for increased urgency, frequency, uui, increased pain and possible uti.She failed to follow-up for refill of vesicare in (b)(6) 2012.Since off this medication, she had terrible urgency and frequency, with urgency incontinence and was using poise pads.She also had 1 episode of possible gross hematuria a week ago.Additionally, the patient reported recurring pain that was 10/10.The pain was not related bowel or bladder function.She was on a long acting narcotic for her generalized pain issues.On the same day, pudendal nerve block procedure was performed.20mg/2ml of kenalog and 9ml of 0.5% marcaine were injected in each side.Procedure well tolerated.Major improvement noted 15 minutes after injection.On (b)(6), 2014, the patient reported generalized groin pain that improved for a week after pudendal nerve block in (b)(6) 2014 but then the symptoms returned.She reported constant sharp, shooting vaginal pains that radiate to abdomen and having difficulty walking.She used a cane to ambulate.She would like to have the mesh removed.Furthermore, the patient reported that she was still having urinary urgency, urgency incontinence.She took vesicare with some relief but ran out of medication.She stopped using vaginal estrogen cream as it caused burning.She also started on spironolactone for leg swelling.She has chronic pain, fibromyalgia and peripheral neuropathy and was on methadone and oxycodone.On (b)(6), 2014, the patient underwent vaginal excision of mesh, cystocele repair, enterocele repair and cystourethroscopy procedures for the treatment of mechanical complication of vaginal mesh and implant and chronic pelvic pain.Postoperative diagnoses were noted as the same plus enterocele.No patient complications after the procedure.The patient was transferred to the recovery room in stable condition.On (b)(6) 2014, the patient presented for routine postop care.She reported no urinary changes since last visit except some new onset dysuria for which she had ua (to restart vaginal estrogen if urine culture grows).She was still at her baseline with urge incontinence and denied sui.She reported 10 days ago episode n/v and since then that time she complained of abdominal pain with decreased appetite.She reported an extensive history of adhesive disease.On (b)(6), 2014, she reported worsening low abdominal diffuse pain that was radiating to both sides at that time; dysuria; felt hot and would turn the air conditioner up strong then she would have chills on occasion but no measured temperatures (within normal limit during the visit); and using chronic narcotics without improvement.On (b)(6) 2015, she presented for a physical exam.She has no new medical complaints.Screening assessments: location of pain: vagina, duration of pain: <30 mins, character of pain: sharp.
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Manufacturer Narrative
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Additional information: blocks a2, b5, h6: patient codes.Block b3 date of event: date of event was approximated to (b)(6), 2009, implant date, as no event onset date was reported.Block e1: this event was reported by the patient's legal representation.Additional attorneys for the patient: (b)(6).Surgeon: (b)(6).Block h6: patient codes e1715, e2314, e2314, e1302, e2338, e2101, e2330, e1002, e1405, e1301, e211401, e1906, e1901, e1309, e2326, e2015 and capture the reportable events of scar tissue, fistula, nerve damage, hematuria, adhesion, pain, abdominal pain, dyspareunia, dysuria, organ perforation, infections, pseudomonas, urinary retention, urinary tract infection, atrophic vaginitis and erosion.Impact codes f1903, f2303 and f1204 capture the reportable events of mesh removal, medications and permanent injury.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to august 19, 2009, implant date, as no event onset date was reported.Block e1: this event was reported by the patient's legal representation.Additional attorneys for the patient: (b)(6).Surgeon: (b)(6).Block h6: patient codes e1715, e2314, e2314, e1302, e2338, e2101, e2330, e1002, e1405, e1301, e211401, e1906, e1901, e1309, e2326, e2015 and e2006 capture the reportable events of scar tissue, fistula, nerve damage, hematuria, adhesion, pain, abdominal pain, dyspareunia, dysuria, organ perforation, infections, pseudomonas, urinary retention, urinary tract infection, atrophic vaginitis and erosion.Impact codes f1903, f2303 and f1204 capture the reportable events of mesh removal, medications and permanent injury.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a pinnacle pelvic floor repair mesh was implanted into the patient during a procedure performed on (b)(6) 2009 for the treatment of pelvic organ prolapse, cystocele, rectocele, and enterocele.As reported by the patient's attorney, sometime after the procedure, the patient began experiencing severe and debilitating pain, infections and dyspareunia.The patient has experienced mental and physical pain and suffering, including erosion, mesh contraction, fistula, inflammation, scar tissue, organ perforation, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, and chronic pelvic pain, and has sustained permanent injury.Subsequently, the patient has been forced to undergo extensive medical treatment including, but not limited to, operations to locate and remove mesh on june 11, 2014, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.Reportedly, the patient continues to suffer serious bodily injury and harm.She continues to receive medical treatment and is anticipated to undergo further medical treatment and surgeries to remove more mesh.This report was originally submitted via asr.Report identification number: (b)(4).Submission period: september 1, 2015 to october 31, 2015.Asr exemption number: e2013036.Pro code: otp.Additional information received on january 14, 2022: the patient was implanted with a pinnacle pelvic floor repair mesh during an anterior/apical compartment, sacrospinous ligament fixation and cystoscopy procedure performed on (b)(6) 2009.It was noted that the surgery included larger than anticipated blood loss but the patient remained hemodynamically stable and mild surgical anemia was resolving with iron.After the procedure, the patient experienced vaginal burning, incomplete bladder emptying and uti for which she initially took keflex on (b)(6) 2009.However, this was changed to levaquin 500mg daily for seven days when urine culture sensitivities returned on september 3, 2009 (urine culture taken on september 3, 2009 showed pseudomonas 50-100k).During her last visit at that time, a urine culture was sent and returned no growth.Secondary to her high pvrs, the patient was kept on macrobid suppression.On november 20, 2009, the patient reported the following: 1.Feeling fatigued and occasionally lightheaded which was new since her last visit 2.Burning sensation resolved.3.Shooting sharp pains in the vagina and subsequent discharge (the pain is very short lived and resolves on its own.This occurs 3-4 times per day and had been going on for a month.The pain rates a 7-8/10 when it occurs).4.Focal pruritus.On her physical exam on that day, it was noted on vagina a 1-2cm granulation tissue at incision line along mid anterior wall that was tender to palpation.No tenderness over mesh at arcus and no mesh erosion was noted.Silver nitrate was applied to the granulation tissue.On apex, the cuff was noted well healed.The patient has pain at the vaginal apex on each side where the mesh anchors into the sacrospinous ligament.Assessments on that time included: 1.Vaginal vault prolapse after hysterectomy - resolved.2.Cystocele, midline, asymptomatic, mostly periurethral.3.Enterocele - resolved.4.Rectocele - resolved.5.Chronic abdominal pain - with a history of multiple laparotomies and bowel resections for sbo (small bowel obstruction), known severe adhesive disease.6.Urgency of urination - resolved off vesicare.7.Urge incontinence - resolved off vesicare.8.Nocturia - resolved off vesicare.9.Levator muscle weakness - mild.10.Atrophic vaginitis - mild.11.Detrusor overactivity.12.Decreased bladder capacity, normal compliance up to 250cc, no prolapse, reduced usi.13.Incomplete bladder emptying postoperatively with pvr 210 cc - asymptomatic.14.Granulation tissue, treated with silver nitrate.15.Vaginal shooting pain, may be due to mesh insertion at ssl based on the exam, or granulation tissue as she had pain with palpation of this site and described discharge immediately after the pain.Plans noted included: 1.The physician had a discussion with the patient regarding possible neuropathic origin of her pain if the mesh insertion point entrapped a nerve and the possibility of using lyrica to help with neuropathic pain.The patient also has history of fibromyalgia and this may help with her fibromyalgia pain.The patient was explained the possible side effects of the medication including sedation, and suicidality and counseled to stop the medication if either if the sedation becomes bothersome or she develops suicidality.A patient handout regarding drug information on lyrica was also given.Lyrica 100mg three times a day was started.2.Patient to follow-up in 3-4 weeks on her pain symptoms.Possible options were discussed if the pain does not resolve including cutting the mesh arms, though her prolapse may recur.Anesthetic and steroids injection to the sacrospinous ligament could also be considered.3.The patient was to continue antibiotic suppression if urinary retention persisted.If not worsening, the patient will be evaluated further if symptomatic and bothersome.On (b)(6) 2009, the patient reported that she self-discontinued lyrica as it made her excessively sleepy for two days after the first dose.She had no additional complaints at that time and felt well in general.No more incidence of uti since she had been on macrobid.Lightheadedness, burning sensation, vaginal pain and focal pruritis resolved.Plans at that time included: 1.High pvr continue on prophylactic macrobid for suppression of uti.Refill for macrobid given.2.Vaginal pain resolved.3.Return to clinic in 1 year for follow up visit.On (b)(6) 2012, the patient complained of urinary frequency, urgency and minor leaking uui (urge urinary incontinence) for a month.She had mild dysuria at that time.She suspected that she had a uti and would like to be tested.On exam, some mild recurrent prolapse was noted that was asymptomatic.Plans noted during the visit: 1, urine culture sent, to contact patient with the results.2.Patient to continue routine flu with pcp and cardiologist tor health care maintenance.3, reassured patient regarding normal pelvic exam with good vaginal support and normal bladder emptying.4.Can consider restarting vesicare if urine culture returns negative.On (b)(6) 2012, the patient reported the following: left sided pain low in groin or vagina that had started 3 weeks previously; described as sharp pain that is worse when walking or moving and is better when lying down; pain that lasts for seconds and hurts so bad that it makes her stop walking; heaviness in lower stomach; still having urgency, frequency, nocturia and uui refractory to vesicare 5mg; worse symptoms; and fecal incontinence (x2 during sleep).On physical exam, the patient had tenderness to palpation over the proximal anterior wall near mesh arms that insert into la near ischial spines and apically on each lateral fornix that reproduces the pain she feels vaginally and on her left side.Assessments at that time included incomplete bladder emptying postoperatively - asymptomatic, elevated pvr (161 ccs); and pelvic pain radiating to the left leg when walking.The pain seemed to localize to the mesh.The patient had postoperative pain that resolved.No change in the position of the mesh on exam.Plan: 1.The physician discussed options of 1) observation and pain management; 2) trial of trigger point injections into obturators and possibly pudendal block; 3) excision of vaginal mesh and or obturator arms.The patient preferred to try a local block.2.Urine sent for culture.To notify the patient if uti.3.Follow-up in 2 weeks for trigger point injections.4.Repeat pvr at f/u appt and if normal, consider increasing vesicare to 10 mg.On (b)(6) 2012, the patient presented for local injection, trigger point at obturator internus muscles near ischial spine and pudendal nerve block at insertion of the apical arm to the ssl.Pvr was 205 ccs.The patient reported pain relief upon injection on the left side.Plan at that time included: 1.Patient to monitor for further improvement at home.If the injection does not resolve or improve the pain, she was discussed about having a surgery.However, she said she would rather live with the pain than have to return to the or for mesh excision.2.Follow up in 2-3 weeks.3.If the retention persists, repeat pvr at follow up appointment.On (b)(6) 2012, the presented for a follow-up visit and reported that her pain had completely resolved following the trigger point injections in october.Pvr was 4 ccs.Assessment at that time noted resolved postoperative incomplete bladder emptying, pelvic pain radiating to l leg when walks that had resolved following trigger point injections, and pudendal neuralgia that had resolved following trigger point injections.On (b)(6) 2014, the patient presented for increased urgency, frequency, uui, increased pain and possible uti.She failed to follow-up for refill of vesicare in (b)(6) 2012.Since off this medication, she had terrible urgency and frequency, with urgency incontinence and was using poise pads.She also had 1 episode of possible gross hematuria a week ago.Additionally, the patient reported recurring generalized vaginal pain, described as sharp and shooting 10/10 severity that lasts for 1-2 seconds and occurred a few times per daypain that was 10/10.The pain was not related bowel or bladder function nor movement or rest.She was on a long-acting narcotic for her generalized pain issues.On the same day, pudendal nerve block procedure was performed.20mg/2ml of kenalog and 9ml of 0.5% marcaine were injected in each side.Procedure well tolerated.Major improvement noted 15 minutes after injection.Vesicare was refilled for urgency/frequency, urine culture was sent, and the patient was to follow up in 4 weeks is the pain continued or returned to discuss repeat injection versus vaginal mesh removal.On (b)(6) 2014, the patient reported generalized groin pain that improved for a week after pudendal nerve block in (b)(6) 2014 but then the symptoms returned.She reported constant sharp, shooting vaginal pains that radiate to abdomen and having difficulty walking.She used a cane to ambulate.She would like to have the mesh removed.Furthermore, the patient reported that she was still having urinary urgency, urgency incontinence.She took vesicare with some relief but ran out of medication.She stopped using vaginal estrogen cream as it caused burning.She also started on spironolactone for leg swelling.She has chronic pain, fibromyalgia and peripheral neuropathy and was on methadone and oxycodone.On (b)(6) 2014, the patient underwent vaginal excision of mesh, cystocele repair, enterocele repair and cystourethroscopy procedures for the treatment of mechanical complication of vaginal mesh and implant, cystocele, and chronic pelvic pain.Postoperative diagnoses were noted as the same plus enterocele.No patient complications after the procedure.The patient was transferred to the recovery room in stable condition.On (b)(6) 2014, the patient presented for routine postop care.She reported no urinary changes since last visit except some new onset dysuria for which she had ua (to restart vaginal estrogen if urine culture grows).She was still at her baseline with urge incontinence and denied sui.She reported 10 days ago episode n/v and since then that time she complained of abdominal pain with decreased appetite.She reported an extensive history of adhesive disease.Exam revealed well healed incisions and minimal tenderness on bimanual exam, much improved from before mesh removal.Urinalysis showed 2+ leukocytes, and urine culture grew >100k e.Coli.Macrobid was prescribed and pyridium was also dispensed.On (b)(6) 2014, she reported worsening low abdominal diffuse pain that was radiating to both sides at that time; dysuria; felt hot and would turn the air conditioner up strong then she would have chills on occasion but no measured temperatures (within normal limit during the visit); and using chronic narcotics without improvement.Basic metabolic panel and complete blood count were ordered.On (b)(6) 2015, she presented for a physical exam.She has no new medical complaints.Screening assessments: location of pain: vagina.Duration of pain: <30 mins.Character of pain: sharp.
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