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

Model Number PP1510X3

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Incontinence (1928); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Dysuria (2684); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 vaginal vault prolapse. It was reported that after the implant, the patient experienced an unspecified adverse outcome.

• Brand Name: PARIETENE
• 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: 10259581
• MDR Text Key: 198388605
• Report Number: 9615742-2020-01566
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: NONE
• 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: 01/08/2021

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/10/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 01/31/2018
• Device MODEL Number: PP1510X3
• Device Catalogue Number: PP1510X3
• Device LOT Number: SNB0083
• 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: 12/16/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/27/2013
• 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: 07/10/2020 Patient Sequence Number: 1

Treatment

174006 PROTACK 5MM DISP IN (LOT# UNKNOWN)