BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE RELIANT

    MDR report key: 1057044 · Received May 23, 2008

    Report

    Report Number
    1057044
    Event Type
    Death
    Date Received
    May 23, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 21, 2008
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED FROM WHEELCHAIR TO BED USING INVACARE RELIANT 450 LIFT WITH INVACARE FULL BODY POLYESTER MESH SLING. WHILE BEING TRANSFERRED A "TEARING" SOUND WAS HEARD. RESIDENT SLID OUT OF LEFT SIDE OF SLING, FALLING TO FLOOR, STRIKING HEAD ON BED FRAME. A 7.5 INCH TEAR WAS FOUND IN THE LEFT SLING ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE RELIANT FULL BODY POLYESTER MESH SLING - LARGE FSA INVACARE CORPORATION R111 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death