BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 4201700 · Received October 27, 2014

    Report

    Report Number
    1531186-2014-05092
    Date Received
    October 27, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    C.T.M. SHANGHAI
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    L-4R SCOOTER. NO SERIAL NUMBER AVAILABLE, OUT OF WARRANTY PER DEALER. THE DEALER STATES THEY ARE MISSING THE BOLT THAT HOLDS THE MOUNTING CLASP OF THE TRANSAXLE AND WHEEL WHICH CAUSED THE CLASP TO BREAK PER TECH. WE DO NOT HAVE PARTS NEEDED. TO REPAIR SCOOTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681508 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. SHANGHAI L-4R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other