BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREECURVE

    MDR report key: 8030532 · Received November 1, 2018

    Report

    Report Number
    3007802293-2018-00043
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    December 6, 2018
    Report Date
    November 1, 2018
    Manufacturer
    HANDICARE STAIRLIFTS B.V
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETROSPECTIVE MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    MRS (B)(6) WAS ON THE STAIRLIFT, COMING DOWN THE STAIRS WHEN THE STAIRLIFT JOLTED (AFTER INSPECTION, 5 TEETH HAD SNAPPED OFF RAIL AND CUSTOMER FELL OFF THE LIFT. CUSTOMER WAS NOT WEARING THE SEATBELT AS SHE SAYS IT IS TOO SMALL FOR HER. BRUISING TO SIDE AND LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867401 FREECURVE STAIRLIFTS PCD HANDICARE STAIRLIFTS B.V

    Patients

    Seq Age Sex Outcome Treatment
    1