BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 4220219 · Received November 3, 2014

    Report

    Report Number
    1531186-2014-05278
    Date Received
    November 3, 2014
    Report Date
    October 10, 2014
    Manufacturer
    C.T.M. SHANGHAI
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PROVIDER STATES THE FRAME IS BROKEN ON THIS SCOOTER. THE END USER WAS TRAVELING DOWN THE SIDE WALK AND STATES IT JUST HAPPENED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701213 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. SHANGHAI L-3B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other