BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE ORIGINAL BED HANDLE - BEDSIDE ASSISTANT

    MDR report key: 218072 · Received April 8, 1999

    Report

    Report Number
    218072
    Event Type
    Death
    Date Received
    April 8, 1999
    Date of Event
    March 27, 1999
    Report Date
    April 8, 1999
    Manufacturer
    BED HANDLES, INC.
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSING ASSISTANT NOTED RESIDENT DRAPED OVER THE BEDSIDE ASSISTANT WITH NO RESPONSE, NO PULSE OR RESPIRATION. THE BEDSIDE ASSIST (A 1 PIECE CONTINUOUS DEVICE) WAS DISLODGED 12-18 INCHES AT THE DISTAL END. THE RESIDENT WAS FOUND DRAPED OVER THE DISTAL LEG THAT WAS PROTRUDING 12-18 INCHES FROM THE BED. THE RESIDENT WAS ON COMFORT CARE DUE TO DECLINE IN CONDITION. SHE USED THE BEDSIDE ASSIST TO PARTICIPATE IN BED MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE ORIGINAL BED HANDLE - BEDSIDE ASSISTANT BEDISDE ASSISTANT FNJ BED HANDLES, INC. BA10W *

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death