BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2317071 · Received October 26, 2011

    Report

    Report Number
    1213643-2011-00572
    Event Type
    Death
    Date Received
    October 26, 2011
    Date of Event
    December 11, 2009
    Report Date
    October 5, 2011
    Manufacturer
    DAVOL 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

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PRODUCT HAS BEEN RETURNED, NO LOT NUMBER OR MEDICAL RECORDS HAVE BEEN PROVIDED, AND NO SPECIFIC PRODUCT PROBLEM BEEN REPORTED. WITHOUT ADD'L INFO, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT UNDERWENT HERNIA REPAIR WITH COMPOSIX KUGEL MESH. THE ATTORNEY ALLEGES THE PT SUBSEQUENTLY SUFFERED PAIN, PERMANENT INJURY AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death