BEUDAMED
    FDA Adverse Event Death Summary report: N

    BEDSIDE ASSISTANT

    MDR report key: 1366564 · Received April 19, 2009

    Report

    Report Number
    MW5010814
    Event Type
    Death
    Date Received
    April 19, 2009
    Date of Event
    February 4, 2002
    Report Date
    April 19, 2009
    Manufacturer
    BED HANDLES INC.
    Product Code
    IKX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS THE STRANGULATION DEATH OF AN APPARENTLY ELDERLY WOMAN, WHO WAS IN AN ASSISTED LIVING SITUATION. PRODUCT WAS INSTALLED ON HER BED IN LATE 2001 AND, SHE DIED IN 2002 OF STRANGULATION IN THIS DEVICE, WHICH IS DESCRIBED IN ITS PATENT AS IN THE FIELD OF BED RAIL AND HANDLE SYSTEMS. MANUFACTURER HAS KNOWN OF THIS DEATH SINCE AT LEAST 2005, WHEN LEGAL ACTION FILED AGAINST IT. MANUFACTURER POSSIBLY NON COMPLAINT WITH REPORTING REQUIREMENT. DATES OF USE: 2001 - 2002. DIAGNOSIS: PREVENT BED FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEDSIDE ASSISTANT BED RAIL IKX BED HANDLES INC. BA10W-6

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death