BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX E/X MESH

    MDR report key: 2978626 · Received February 18, 2013

    Report

    Report Number
    MW5029104
    Event Type
    Injury
    Date Received
    February 18, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BARD MEDICAL DIV
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BARD COMPOSIX E/X MESH REF NUMBER 0123460 LOT NUMBER: 43DOD236 IMPLANTED TO REPAIR A HERNIA ON (B)(6) 2005. AS A RESULT OF THE EROSION OF THIS DEVICE, I HAD SURGERY ON (B)(6) 2013. THE MESH HAD ERODED INTO MY BLADDER AND APPENDIX CAUSING AN INFECTION IN MY ABDOMEN. THE DOCTORS REMOVED MY APPENDIX WHICH WAS OTHERWISE HEALTHY, AND A PORTION OF MY BLADDER. DATES OF USE: (B)(6) 2005-(B)(6) 2013. REASON FOR USE: HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70930 BARD COMPOSIX E/X MESH BARD 3D COMPOSIX MESH FTL BARD MEDICAL DIV 0123460 43DOD236

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| O