BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCORAIL SYSTEM FOR HOME USE

    MDR report key: 68017 · Received February 12, 1997

    Report

    Report Number
    2242298-1997-09001
    Event Type
    Injury
    Date Received
    February 12, 1997
    Date of Event
    November 2, 1996
    Report Date
    February 11, 1997
    Manufacturer
    LCM DISTRIBUTION SYSTEM
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PROUDCT WAS PURCHASED IN 1/96. THE USER OF THE PRODUCT, HAD CANCER AND WAS BEDRIDDEN. ALLEGEDLY ON 11/2, THE BEDRAIL BROKE AND THE USER FELL OUT OF BED AND BROKE HIS HIP. LATER THAT DAY THE USER DIED; NOT AS A RESULT OF THE FALL, BUT DUE TO CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCORAIL SYSTEM FOR HOME USE BED RAIL TO ASSIST WHEN GETTING IN/OUT FNL LCM DISTRIBUTION SYSTEM GF6690-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention