MAUDE Adverse Event Report: ETHICON, INC. PROCEED; MESH, SURGICAL, POLYMERIC

Catalog Number PCDG1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hernia (2240)

Event Date 08/28/2013

Event Type  malfunction  

Event Description

Mesh was implanted.Patient had to return to the operating room 16 days later, as the hole in the mesh had caused a richter hernia, which required repair.A second piece of mesh was implanted.

• Brand Name: PROCEED
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON, INC.; rt. 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 5140051
• MDR Text Key: 27974381
• Report Number: 5140051
• 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: Patient
• Report Date: 08/30/2013,10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: PCDG1
• Device Lot Number: GBG045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2013
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2013
• 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
• Patient Outcome(s): Other