BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1063395 · Received June 19, 2008

    Report

    Report Number
    1213643-2008-00337
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    February 21, 2007
    Report Date
    May 20, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WHILE ADHESIONS ARE A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: 2006 - PATIENT HAD HERNIA REPAIRED DURING WHICH A COMPOSIX KUGEL PATCH WAS USED TO REPAIR THE PATIENT'S HERNIA DEFECT. DUE TO THE MESH, PATIENT SUFFERED SEVERE PERSISTENT ABDOMINAL PAIN, WHICH WAS ACCOMPANIED BY ABDOMINAL DISTENTION AND ABDOMINAL TENDERNESS. IN 2007 - DUE TO THE PATIENT'S CONDITION, THE MESH WAS EXPLANTED. PHYSICIANS DISCOVERED ADHESIONS OVER THE PATIENT'S COLON AND SMALL BOWEL, WHICH WAS DETERMINED TO BE THE CAUSE OF THE PATIENT'S ABOVE DESCRIBED INTENSE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention