BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3103602 · Received May 9, 2013

    Report

    Report Number
    1531186-2013-01992
    Date Received
    May 9, 2013
    Report Date
    April 14, 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

    THE END USER ALLEGED THAT THE SCOOTER STOPPED WORKING (B)(6). THE EDN SUERS STATED SHE CHARGED THE SCOOTER TO THE POINT IT SAYS FULLY CHARGED AND WHEN SHE TURNS THE KEY, IT JUST BLIKNS AND DOESN'T WORK. SHE CLAIMS THE CHAIR TIPPED OVER IN THE PAST. THIS CAUSED BRUISING TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203874 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-3R

    Patients

    Seq Age Sex Outcome Treatment
    1 22 Other