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

Model Number UGYKA

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750); Bruise/Contusion (1754); Purulent Discharge (1812); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Chills (2191); Cramp(s) (2193); Discharge (2225); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Prolapse (2475); Skin Tears (2516); Dysuria (2684); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038b) and is now being submitted on a 3500a form. Exemption number: (b)(4). 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 of cystocele, vaginal vault prolapse and stress urinary incontinence. It was reported that after implant, the patient experienced pain, nausea, recurrent prolapse, recurrent urinary tract infections, dysuria, lower abdominal cramping, urinary urgency, urinary frequency, fecal incontinence, nocturia, incomplete emptying of bladder, vaginal bruising, mesh erosion (at vaginal apex/proximal anterior wall/top of vagina at cervical vaginal junction/cuff), atrophic vaginitis, acute cystitis (inflammation), vaginal pressure, stricture, vaginal discharge, hyperkeratosis, cracking of skin on genitalia, infection, pelvic organ prolapse, extrusion, increased urinary stream, pressure and discomfort between the rectum and vagina, discomfort riding any distance in a car, small rectocele, fecal incontinence, feeling as though there was a small lemon down below that feels like pressure when she is standing which makes her want to sit down, left labial minora with small area of bruising, stage 1 vaginal prolapse, slight sense of stool trapping, minimal recurrent cystocele between 2 and 3, unspecified bladder issues, pelvic relaxation symptoms, digital defecation, introitus irritation, rectal pain, chills, backache, stricture above the cervix, cracking of the skin noted at the posterior fourchette from hyperkeratosis induced by the discharge from the eroded graft and yellow discharge around the graft. The device had been used with align® to urethral support system. Post-operative patient treatment includes multiple non-surgical interventions but no surgical interventions to date.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• Type of Device: MESH, 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 Key: 8695512
• MDR Text Key: 147878927
• Report Number: 9615742-2019-02182
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2012
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: ZHI00366
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/01/2007
• 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: 06/13/2019 Patient Sequence Number: 1