BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD/DAVOL

    MDR report key: 837605 · Received April 13, 2007

    Report

    Report Number
    MW1042545
    Event Type
    Other
    Date Received
    April 13, 2007
    Date of Event
    November 18, 1999
    Report Date
    April 9, 2007
    Manufacturer
    BARD DAVOL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A VENTRAL HERNIA REPAIR IN 1999. THIS WAS ONE OF THREE SURGERIES IN A 12 MO PERIOD TO REPAIR THE HERNIA. THE IMPLANT OF THE BARD/DAVOL MARLEX MESH PATCH CATALOG #0112650 FAILED. I HAVE HAD RECURRING SIDE EFFECTS. CROHN'S LIKE SYMPTOMS - I DO NOT HAVE CROHN'S DISEASE - THE SYMPTOMS INCLUDE EXTREME PAIN/CRAMPING IN THE AREA OF MY LOWER INTESTINES, COLON, CONSTANT DIARRHEA, BLOATING AND DIFFICULTY PASSING BODY WASTE - VERY LIQUIDY - SINCE 2002. THE ENTIRE HERNIA AREA HAS BEEN PROTRUDING - SINCE 2002 - AND LOOKS LIKE AN EGG ON MY CHEST. IT CAUSES PAIN, AND IS SWOLLEN. I HAVE DISCUSSED THESE ISSUES WITH A COUPLE OF MY MD'S AND WAS TOLD BY THEM THAT I COULD POSSIBLY HAVE IBS, BUT SOON AFTER THE PROTRUSION OF THE IMPLANT OCCURRED, THOSE SYMPTOMS BEGAN, AND HAVE NOT CEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD/DAVOL MARLEX MESH PATCH FTL BARD DAVOL * 43BJD032

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other