BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1150532 · Received September 3, 2008

    Report

    Report Number
    1213643-2008-00415
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    March 14, 2007
    Report Date
    August 4, 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
    RI, 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: 2003 -THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE WITH IMPLANT OF A COMPOSIX KUGEL MESH. FOLLOWING THE SURGERY, THE PATIENT BEGAN EXPERIENCING CHRONIC SEVERE ABDOMINAL PAIN AND A GENERAL FEELING OF NOT BEING WELL. IN 007 - WITH PROGRESSIVELY WORSENING SYMPTOMS, THE PATIENT UNDERWENT SURGERY TO ADDRESS WHAT WAS CAUSING HER ONGOING SYMPTOMS. HER SURGEON DISCOVERED THAT THE PREVIOUSLY PLACED COMPOSIX KUGEL MESH WAS SEVERELY ADHERED TO HER SMALL BOWEL. THE SURGEON HAD TO DISSECT THE MESH AWAY FROM THE SMALL BOWEL, AND THE SEPARATION RESULTED IN A LARGE ENTEROTOMY WHICH REQUIRED IN A SMALL BOWEL RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43JDN207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention