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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 02/01/2013

Event Type  Injury  

Event Description

Implanted bard umbilical hernia mesh failed and had to be removed.Ventralight mesh was implanted as a replacement.Ventralight has now failed and need additional surgery for repair.

• Brand Name: VENTRALEX HERNIA PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): C.R. BARD INC.
• MDR Report Key: 6618489
• MDR Text Key: 76968342
• Report Number: MW5070210
• 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: 06/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 93