MAUDE Adverse Event Report: C.R. BARD, INC. KUGEL HERNIA PATCH; MESH, SURGICAL, POLYMERIC

Lot Number HUAX2001

Device Problem Hole In Material (1293)

Patient Problem Perforation (2001)

Event Date 01/23/2017

Event Type  Injury  

Event Description

Mk patch use for incarcerated left inguinal hernia repair.Patient returned to 4 days post surgery for repair of bladder perforation and retrieval of mesh within the bladder.An approximate 1cm hole was identified in the bladder wall.

• Brand Name: KUGEL HERNIA PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 6629459
• MDR Text Key: 77220077
• Report Number: 6629459
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: HUAX2001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• 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
• Treatment: NO
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR