MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN MESH MESH, SURGICAL, POLYMERIC

Model Number 481068

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Incontinence (1928); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Cramp(s) (2193); Anxiety (2328); Injury (2348); Depression (2361); Obstruction/Occlusion (2422); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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 pelvic organ prolapse and prolapsed colon via bladder sling repair. It was reported that after implant, the patient experienced erosion, painful sex, chronic utis, cramping, pain, constant doctor visits, fear, embarrassment, back pain, nerve damage, incomplete urine voiding, incontinence, manipulation required for bowel movements, scar tissue, fecal bulging out of vagina, adhesions, bleeding, bowel obstruction, cystocele of fecal matter, dyspareunia, muscle wasting disorder, neuromuscular disease, obesity, recurrent vaginal pain, anxiety and depression. Post-operative patient treatment included partial removal surgery antidepressants, mood stabilizers and hormone medications.

• Brand Name: UNKNOWN MESH
• 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: 8908555
• MDR Text Key: 154834213
• Report Number: 9615742-2019-02859
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 481068
• Device Catalogue Number: 481068
• Device Lot Number: 10B07-1
• 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: 07/24/2019
• 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: 08/19/2019 Patient Sequence Number: 1