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

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/10/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, i experienced a bowel obstruction caused by a tear in the bard mesh that i had placed on (b)(6) 2016 for multiple abdominal hernias.They were unable to remove the mesh as i had integrated with my tissues so they repaired it.I am no longer able to lift more than 10 lbs for fear of the mesh failing again.I live in fear of it happening again.I lost my job because as a nurse i was required to lift 50 lbs.I now work in a dr's office part time for 1/2 that i was making an hour.

• Brand Name: BARD VENTRIO HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 7560591
• MDR Text Key: 109901557
• Report Number: MW5077584
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 68 YR
• Patient Weight: 104