MAUDE Adverse Event Report: BARD BARD MESH 6X6; MESH, SURGICAL POLYMERIC

Model Number 0112720

Device Problems Loose or Intermittent Connection (1371); Wrinkled (2614)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

Date the problem occurred a few months after surgery.I had surgery on (b)(6) 2009 for laparoscopic bilateral inguinal hernia repair.The first year after surgery i went back to surgeon (b)(6) twice with pain.The pain was in the lower right side.He looked at it and said it would probably get better.No tests were run.I went to my urologist on (b)(6) 2014 he did a cat scan.It showed on the right side that the lower right corner of the mesh had pulled loose and was wrinkled up.He said that it would be complicated to try to repair and could cause more problems.The patch failed, wrinkled up on the bottom and pulled the anchor out.It causes pain everyday.

• Brand Name: BARD MESH 6X6
• Type of Device: MESH, SURGICAL POLYMERIC
• Manufacturer (Section D): BARD
• MDR Report Key: 6493043
• MDR Text Key: 72966490
• Report Number: MW5069085
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 0112720
• Device Catalogue Number: 0112720
• Device Lot Number: HUTC 1252 QTY - 2
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 98