• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD 3D MAXX HERNIA MESH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD 3D MAXX HERNIA MESH Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3D MAXX HERNIA MESH
Type of DeviceHERNIA MESH
Manufacturer (Section D)
BARD
MDR Report Key7179040
MDR Text Key96954294
Report NumberMW5074506
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number3D MAXX HERNIA MESH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/09/2018 Patient Sequence Number: 1
-
-