MAUDE Adverse Event Report: BARD BARD 3D MAX MESH

Lot Number HUVI0120

Device Problem Folded (2630)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 02/24/2012

Event Type  Injury  

Event Description

Had bi-lateral hernia surgery with mesh implanted. One large piece of bard 3d mesh used to cover a femoral and inguinal hernia together on the right, and another large piece used to cover two inguinal hernias on the left. Bard 3d max lot huvi0120 and huvj0718 and sorbafix lot huvj0760. Since (b)(6) weeks after surgery, have had tremendous pain in right pelvis to pubic bone and down front of leg, and some burning pain in left pelvis. Also had surgical clips used to hold right peritoneum closed. Surgical report says it "opened during the surgery. ".

• Brand Name: BARD 3D MAX MESH
• Type of Device: MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 2660967
• MDR Text Key: 2837524
• Report Number: MW5026193
• 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: 07/15/2012
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2016
• Device Lot Number: HUVI0120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Patient Treatment Data

Date Received: 07/15/2012 Patient Sequence Number: 1