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

Model Number UNKNOWN MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Breast Cancer (1759); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Anxiety (2328); Injury (2348); Prolapse (2475); Weight Changes (2607); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Specific type of mesh product was not available.Procode chosen based on most common mesh procode reported between ftl and otn.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 and stress urinary incontinence.After implant, the patient experienced worse incontinence, lower back pain, chronic abdominal pain.Symptoms occurred within six weeks of implant.The patient also experienced breast cancer, chronic constipation, cystocele recurrence, diverticulitis, dyspareunia, enterocele, hypertension, obesity, rectocele, infections, urinary retention, vaginal vault prolapse, and anxiety.Treatment included pelvic floor reconstruction in 2005, and prescription of zoloft/clozuphin for anxiety.

• 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: 8167133
• MDR Text Key: 130458192
• Report Number: 9615742-2018-02759
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MESH
• Device Catalogue Number: UNKNOWN MESH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2018
• 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): Required Intervention
• Patient Weight: 68