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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UGY1510
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Micturition Urgency (1871); Incontinence (1928); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Ulceration (2116); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Numbness (2415); Prolapse (2475); Blood Loss (2597); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient's attorney alleged a deficiency against the device. Product was used for therapeutic treatment of incontinence, prolapse, and urethral stricture. The procedure involved a total vaginal hysterectomy, cystoscopy, urethral dilation, anterior repair with the mesh, pubovaginal sling implant, posterior repair, and sacrospinous ligament fixation. Difficulty with urethral stricture and mild trabeculation of the bladder was noted. After implant, the patient experienced chronic pelvic/abdominal, buttock/perineal/pudendal nerve/ischial tuberosity/labia/bladder/myofascial/urethral pain, vaginal discharge, urethral stricture, pudendal nerve entrapment, vaginal/pelvic discomfort, urgency, frequency of urination, nocturia, mesh erosion at the anterior apex, ulceration, colpospasm, blood loss, dyspareunia, urinary retention, vulvar/leg numbness and burning, neuropathy/neuralgia/neuritis, rectal/vaginal spasms, recurrence of incontinence, recurrence of prolapse, diarrhea, chronic constipation, and colitis. Symptoms began within two months after implant. Treatment provided after the initial procedure includes surgical release of the sacrospinous ligament fixation ((b)(6) 2009), mesh revision ((b)(6) 2011, (b)(6) 2011, (b)(6) 2017, and (b)(6) 2017), pudendal nerve blocks ((b)(6) 2012, (b)(6) 2012, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2016, late 2016, (b)(6) 2017, (b)(6) 2018, and (b)(6) 2018), diagnostic bilateral l3-l5 medial branch nerve block ((b)(6) 2015, (b)(6) 2015), physical therapy ((b)(6) 2010 - (b)(6) 2010), prolonged hospital stay ((b)(6) 2017), bilateral l3-l5 nerve radiofrequency denervation ((b)(6) 2018), multiple medical consultations between 2009 to present, and prescription of medical marijuana in 2018 for pain. Mesh revision on (b)(6) 2017 involved revision of sacrospinous fixation, vaginal graft revision, posterior repair, cystoscopy, and labial biopsy. Revision on (b)(6) 2017 involved laparoscopic colpopexy, enterocele repair, cystoscopy, anterior repair, vaginal graft revision, sling revision, and release of sacrospinous fixation. Admitted to the hospital for abdominal pain and diarrhea from (b)(6) 2017 to (b)(6) 2017, found to have colitis; sigmoidoscopy performed and patient administered probiotics.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameMESH SOFRADIM - UGYTEX¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north have, CT 06473
2034925563
MDR Report Key8174402
MDR Text Key130668260
Report Number9615742-2018-02804
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUGY1510
Device Catalogue NumberUGY1510
Device LOT NumberPJC00738
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/18/2018 Patient Sequence Number: 1
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