BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE

    MDR report key: 369005 · Received December 28, 2001

    Report

    Report Number
    369005
    Event Type
    Death
    Date Received
    December 28, 2001
    Date of Event
    December 12, 2001
    Report Date
    December 26, 2001
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RESIDENT WAS FOUND UNRESPONSIVE, HANGING OUT OF BED WITH RESIDENT'S HEAD THROUGH THE SIDERAILS, BY STAFF ON REGULAR ROUNDS. RESIDENT APPARENTLY TRIED TO GET OUT OF BED UNASSISTED AND GOT HEAD CAUGHT BETWEEN THE SIDERAIL BARS, RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58775 INVACARE SIDERAILS FNJ INVACARE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death