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U.S. Department of Health and Human Services

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

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BARD BARD COMPOSIX L/P MESH Back to Search Results
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.
 
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Brand NameBARD COMPOSIX L/P MESH
Type of DeviceMESH
Manufacturer (Section D)
BARD
MDR Report Key6321730
MDR Text Key67265376
Report NumberMW5067804
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
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 Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0134460
Device Lot NumberHUSJD7SA
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 02/09/2017 Patient Sequence Number: 1
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