BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1892394 · Received November 3, 2010

    Report

    Report Number
    1213643-2010-00467
    Event Type
    Death
    Date Received
    November 3, 2010
    Date of Event
    October 10, 2007
    Report Date
    October 8, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0760-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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 BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. NO MFG ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: (B)(6) 2003: PT HAD A COMPOSIX KUGEL MESH IMPLANTED TO REPAIR A HERNIA DEFECT. ON (B)(6) 2007: PT PRESENTED TO THE HOSP FOR EXCISION OF THE COMPOSIX KUGEL MESH. THE INJURIES THE PT SUSTAINED BECAUSE HIS COMPOSIX KUGEL PATCH FAILED WERE SEVERE AND THEY CAUSED HIS DEATH. PT DIED ON (B)(6), 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43END467

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R