BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 4040229 · Received August 27, 2014

    Report

    Report Number
    1531186-2014-03555
    Date Received
    August 27, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 28, 2014
    Manufacturer
    C.T.M. SHANGHAI
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED THE SCOOTER WILL JUST STOP AND FLASH. IF SHE TURNS IT OFF AND GIVES IT A FEW, SHE CAN TURN IT ON AND IT WILL GO A BIT LONGER AND REPEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519723 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. SHANGHAI L-4B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 MO Other