MAUDE Adverse Event Report: COVIDIEN PARIETEX COMPOSITE MESH, SURGICAL, POLYMERIC

Model Number N/A

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

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 05/21/2014

Event Type  Malfunction  

Event Description

Removal of infected mesh. Infected parietex mesh with subfascial abscess.

• Brand Name: PARIETEX COMPOSITE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN; 60 middletown avenue; north haven CT 06473
• MDR Report Key: 5418789
• MDR Text Key: 37739337
• Report Number: 5418789
• 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: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/19/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/09/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device MODEL Number: N/A
• Device Catalogue Number: PCO3020
• Device LOT Number: PJB00391
• OTHER Device ID Number: 30 X 20 CM
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2015
• Event Location: Hospital
• Date Report TO Manufacturer: 11/19/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage