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

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.

• 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: 8111479
• MDR Text Key: 128625603
• Report Number: 9615742-2018-02629
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2016
• Device Model Number: UGY1510
• Device Catalogue Number: UGY1510
• Device Lot Number: P24209G3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR