BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3222850 · Received July 12, 2013

    Report

    Report Number
    1531186-2013-03127
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END-USER STATES OPENED THE UNIT OUT OF THE BOX AND TRIED TO REMOVE SEAT. END-USER COULDN'T REMOVE SEAT, SO END-USER PUT SCOOTER ON IT'S SIDE, AND THE SCOOTER FELL ON THE END-USER'S LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324441 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-4R

    Patients

    Seq Age Sex Outcome Treatment
    1 91 Other