BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED HANDLES

    MDR report key: 1366563 · Received April 17, 2009

    Report

    Report Number
    MW5010813
    Event Type
    Death
    Date Received
    April 17, 2009
    Date of Event
    March 9, 2007
    Report Date
    April 17, 2009
    Manufacturer
    BED HANDLES INC.
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BED HANDLES IS BED RAIL DEVICE THAT HAS HORIZONTAL STRUTS THAT GO UNDER THE MATTRESS. AT THE EDGE OF THE BED THEY TURN UPWARD, CREATING A BED HANDLE. ALTHOUGH COATED WITH A FRICTION COATING, THERE IS NO OTHER MECHANICAL MEANS TO PREVENT THE RAIL FROM MOVING AWAY FROM THE BED WITH PRESSURE FROM THE PATIENT. IN THIS CASE, A SINGLE RAIL DID MOVE PARTLY AWAY FROM THE BED AND, A PT PHYSICALLY FRAIL WOMAN WITH DEMENTIA FELL INTO THE SPACE BETWEEN THE VERTICAL RAIL STRUTS AND THE MATTRESS, AND WAS HELD IN POSITION BY THE HORIZONTAL STRUTS. SHE DIED OF ASPHYXIA. THE MANUFACTURER HAS KNOWN OF THIS EVENT AND FAILED TO FILE A MANDATORY REPORT, AND APPARENTLY HAS BEEN NON COMPLIANT WITH POST MARKETING SURVEILLANCE IN AT LEAST ONE OTHER INSTANCE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED HANDLES NONE IKX BED HANDLES INC. BA10W

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death