BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3151015 · Received June 6, 2013

    Report

    Report Number
    1531186-2013-02480
    Date Received
    June 6, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 10, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS BRAKES DID NOT HOLD, ROLLATOR SPUN HIM OUT AND HE FELL FORWARD AND CUT HEAD. NEXT DAY IT FLIPPED HIM BACKWARDS AND HURT BACK AND RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251148 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Other