MAUDE Adverse Event Report: BARD 3D MAXX HERNIA MESH

Model Number 3D MAXX HERNIA MESH

Device Problems Bent (1059); Folded (2630)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

In 2011 i had hard 3d maxx hernia mesh implanted for an inguinal hernia repair.I had been in pain for many years.Drs and tests couldn't find anything wrong.In (b)(6) 2017, the pain increased and new debilitating symptoms occurred in my groin region.A specialist in a different state saw on a cat scan that the mesh was bent and shifted.I had to have surgery to remove the mesh.It was found to be folded on itself and bunched up into a ball and hard.

• Brand Name: 3D MAXX HERNIA MESH
• Type of Device: HERNIA MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 7179040
• MDR Text Key: 96954294
• Report Number: MW5074506
• 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: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3D MAXX HERNIA MESH
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 68