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

Model Number PCOPM15

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Internal Organ Perforation (1987); Renal Failure (2041); Seroma (2069); Hernia (2240); Peritonitis (2252); Injury (2348); Ascites (2596); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 incisional hernia. It was reported that after implant, the patient experienced extensive adhesions, recurrence, bowel incarceration, seroma and perforation in the conduit with urinoma. Post-operative patient treatment included lysis of adhesions, explant of previous mesh and repair of hernia with new mesh.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. 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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a herniorrhaphy incisional laparoscopic ro. He had revision surgery 2 days post-surgery. The patient experienced surgical revision, extensive adhesions, perforation in the conduit with urinoma.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7171481
• MDR Text Key: 280476566
• Report Number: 9615742-2018-00046
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177758
• UDI-Public: 10884521177758
• Combination Product (y/n): N
• PMA/PMN Number: K081126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2017
• Device Model Number: PCOPM15
• Device Catalogue Number: PCOPM15
• Device Lot Number: PMK00297
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 01/08/2018 Patient Sequence Number: 1