BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1892396 · Received November 3, 2010

    Report

    Report Number
    1213643-2010-00469
    Event Type
    Death
    Date Received
    November 3, 2010
    Report Date
    October 12, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED OR REQUEST FOR ADDITIONAL INFO HAS NOT BEEN RESPONDED TO. NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADDITIONAL INFO INCLUDING PT INFO, COPIES OF MEDICAL INFO/RECORDS AND DEATH CERTIFICATE/AUTOPSY REPORT HAVE BEEN REQUESTED. A DHR REVIEW HAS NOT BEEN CONDUCTED, SINCE NO SPECIFIC PRODUCT CODE OR LOT NUMBER HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: PT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH HER USE OF DEFECTIVE PRODUCT, THE BARD COMPOSIX KUGEL MESH. SPECIFICALLY, AS A RESULT OF HAVING THE COMPOSIX KUGEL MESH PATCH IMPLANTED IN PT, PT SUFFERED DISABLING PAIN, REQUIRED SURGICAL INTERVENTION AND DIED AS A RESULT OF COMPLICATIONS CAUSED BY THE COMPOSIX KUGEL MESH PATCH.

    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 Death| R