MAUDE Adverse Event Report: ETHICON ETHICON PHYSIOMESH ETHICON HERNIA MESH

Model Number PHY 1520V

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 04/15/2011

Event Type  Malfunction  

Event Description

Laparoscopic ventral hernia repair with ethicon mesh. Mesh pulled away from abdominal wall resulting in 2nd surgery laparoscopic & open (laparotomy) removal of mesh, repair of recurrent ventral hernia using bard mesh.

• Brand Name: ETHICON PHYSIOMESH
• Type of Device: ETHICON HERNIA MESH
• Manufacturer (Section D): ETHICON; route 22 west; somerville NJ 08876 015
• MDR Report Key: 2069574
• MDR Text Key: 18179611
• Report Number: 2069574
• Device Sequence Number: 1
• Product Code: FTL

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: RISK MANAGER
• Type of Report: Initial
• Report Date: 04/19/2011

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/19/2011
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: INVALID DATA
• Device MODEL Number: PHY 1520V
• Device LOT Number: CH9CS220
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No Answer Provided
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2011
• Event Location: Hospital