BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLAMP-ON HALFRAIL

    MDR report key: 258074 · Received January 6, 2000

    Report

    Report Number
    MW1017894
    Event Type
    Death
    Date Received
    January 6, 2000
    Date of Event
    January 2, 2000
    Report Date
    January 4, 2000
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    FNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REP TELLS REPORTER THAT DEVICES ARE MADE IN TAIWAN BUT MEDLINE IS LISTED AS THE MFR. PLEASE BE ADVISED OF AN INCIDENT WHICH OCCURRED IN FACILITY WHERE ONE OF THE HALF RAILS MAY HAVE CONTRIBUTED TO THE DEATH OF A RESIDENT. ALTHOUGH THE CAUSE OF DEATH HAS NOT BEEN DEFINITELY DETERMINED, THE RESIDENT WAS FOUND SITTING ON THE FLOOR NEXT TO HER BED WITH HER HEAD LODGED BETWEEN THE RAIL AND THE BED MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAMP-ON HALFRAIL TELESCOPIC SIDERAIL FNJ MEDLINE INDUSTRIES INC MDS89695 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death