BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDICARE

    MDR report key: 17836931 · Received September 28, 2023

    Report

    Report Number
    3005753836-2023-00001
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 27, 2023
    Manufacturer
    HANDICARE STAIRLIFTS B.V.
    Product Code
    PCD
    UDI-DI
    8719326254326
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT WILL BE BROUGHT BACK TO DISTRIBUTION FACILITY IN CANADA FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER WAS ATTEMPTING TO SIT ON THE UNIT AND CHAIR SLIDE DOWN THE RAIL STAIRLIFT RAIL. THE USER WAS EJECTING EJECTED FROM THE CHAIR ONTO THE FLOOR. HIS BROTHER CALLED AN AMBULANCE. USER WAS REPORTEDLY ADMITTED TO HOSPITAL FOR 2 DAYS AND NOW OUT DOING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099274 HANDICARE STAIR CHAIR LIFT PCD HANDICARE STAIRLIFTS B.V. 1100 8719326254326

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization