MAUDE Adverse Event Report: BARD BARD COMPOSIX L/P MESH

Catalog Number 0134460

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nerve Damage (1979); Pain (1994); Obstruction/Occlusion (2422); Hematuria (2558)

Event Date 06/30/2009

Event Type  Injury  

Event Description

On (b)(6) 2009 had laparoscopic hernia repair with bard composix l/p mesh.In 2011, he had revision surgery and 4 days later he had to have an emergency surgery due to a hematoma which he almost died.In (b)(6) 2016 had two bowel obstruction and the complications is really causing him problems.Patient is scheduled to consult with surgeon on (b)(6) 2017 to see if mesh can be taken out.Patient has been in pain ever since he had the mesh implanted.Patient never thought the mesh would cause him such problems: tooth loss, nerve damage in his leg, stomach obstruction, can't eat,or drink without his stomach hurting, pain during sex and urination problem.

• Brand Name: BARD COMPOSIX L/P MESH
• Type of Device: MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 6321730
• MDR Text Key: 67265376
• Report Number: MW5067804
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0134460
• Device Lot Number: HUSJD7SA
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR