BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3921206 · Received July 9, 2014

    Report

    Report Number
    1531186-2014-02446
    Date Received
    July 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    C.T.M. SHANGHAI
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER ALLEGES THE L-4R SCOOTER WILL GO FORWARD OR BACKWARDS AND THE UNIT WILL SHUTS DOWN. DEALER HAS THE SCOOTER. DEALER TEST DROVE IT AND IT SHUT DOWN AFTER A FEW SECONDS. DEALER STATES THAT IT BLINKS 6 TIMES AND TECH SERVICES EXPLAINED THAT IT IS A THROTTLE POT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400399 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. SHANGHAI L-4R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other