BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 163449 · Received April 20, 1998

    Report

    Report Number
    MW1013536
    Event Type
    Death
    Date Received
    April 20, 1998
    Date of Event
    April 15, 1998
    Report Date
    April 20, 1998
    Manufacturer
    HBR HEALTHCARE CO
    Product Code
    FNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER IS CALLING TO REPORT ON A BEDRAIL WHICH HE STRONGLY FEELS POSES A DANGER TO HIS RESIDENTS. ACCORDING TO THE REPORTER, THE RESIDENT WAS FOUND IN BED WITH HIS HEAD BETWEEN THE VERTICAL BARS OF THE BEDRAIL. THE RESIDENT HAD EXPIRED. THE CAUSE OF DEATH WAS RULED AS PNEUMONIA. THE REPORTER IS CONCERNED BECAUSE HE WAS UNAWARE A RESIDENT'S HEAD COULD FIT BETWEEN THE VERTICAL BARS. REPORTEDLY, THE GAP BETWEEN THE BARS IS 7 1/2 INCHES. ALTHOUGH THE BEDRAIL WAS NOT IMPLICATED IN THIS PARTICULAR DEATH, THE REPORTER FEELS IT COULD EASILY LEAD TO SERIOUS INJURY OR DEATH IF A RESIDENT WAS ENTRAPPED. THE BEDRAILS WERE PURCHASED SEPARATELY FROM THE BEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK BEDRAIL: 1/2 LENGTH FNJ HBR HEALTHCARE CO 301 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death