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

1 Device was Involved in the Event

1 Patient was 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 This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1