BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 4212954 · Received October 30, 2014

    Report

    Report Number
    1531186-2014-05205
    Date Received
    October 30, 2014
    Report Date
    October 8, 2014
    Manufacturer
    C.T.M. TAIWAN
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES, THE HINGE ON THE SEAT BROKE PATIENT IS UNAWARE AS TO HOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695613 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. TAIWAN LEO-3S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other