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

Model Number PCO4VP

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hernia (2240); Injury (2348)

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 of an incarcerated ventral hernia.It was reported that after implant, the patient experienced recurrence, mesh contracture, and adhesions.Post-operative patient treatment included revision surgery, mesh resected, and hernia repair with new mesh.

• Brand Name: PARIETEX
• 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: 10513672
• MDR Text Key: 206295256
• Report Number: 9615742-2020-01980
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521165700
• UDI-Public: 10884521165700
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120506
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PCO4VP
• Device Catalogue Number: PCO4VP
• Device Lot Number: PQC0372X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/10/2020
• Date Device Manufactured: 03/23/2016
• 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
• Treatment: PCO4VP PCO VENTRAL PATCH 4CM X1 (LOT # PQC0372X)
• Patient Outcome(s): Required Intervention