• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UGY1510
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Ecchymosis (1818); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Prolapse (2475); Abdominal Distention (2601); No Code Available (3191)
Event Type  Death  
Manufacturer Narrative

This event was previously reported to the fda on an alternative summary report (asr approval #: (b)(4), 05-31-2016) and is now being submitted on a 3500a form because of newly received information that the patient is now deceased. 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. The product was used for therapeutic treatment. It was reported that after implant, the patient experienced surgical interventions per medical records for complete procidentia, intrinsic sphincter deficiency, occult stress urinary incontinence, pain, urinary problems, recurrence and dyspareunia after implantation, severe anterior wall prolapse, moderate atrophy, vaginal cuff prolapse, left posterior wall prolapse, significant discomfort, embarrassment, confined to house, depression, anxiety, and possible post-traumatic stress disorder concerning her surgery, occult stress urinary incontinence, recurrent vaginal vault prolapse, anterior repair with gynecare prolift, paravaginal suspension with gynecare prolift, sacrospinous vaginal vault suspension, gynecare tension free vaginal tape, followed by postoperative incontinence, ecchymosis of the bilateral labia majora, detrusor instability, anemia, pelvic hematoma, large umbilical hernia, urinary leakage requiring diapers, urinary retention and bladder distention requiring foley catheter placement and antibiotics, overflow incontinence, urodynamic testing, intrinsic sphincter deficiency, diagnostic cystoscopies, repeat gynecare tension free vaginal tape placement, recurrent urinary tract infections, urgency, frequency, and urge incontinence. The patient has required multiple surgical and non-surgical interventions. The patient also alleged she experienced removal of mesh, pain and dyspareunia. The patient is now deceased.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 haven, CT 06473
2034925563
MDR Report Key8111479
MDR Text Key128625603
Report Number9615742-2018-02629
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK051503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 11/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/30/2016
Device MODEL NumberUGY1510
Device Catalogue NumberUGY1510
Device LOT NumberP24209G3
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
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: 11/28/2018 Patient Sequence Number: 1
-
-