BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3110106 · Received May 13, 2013

    Report

    Report Number
    1531186-2013-02022
    Date Received
    May 13, 2013
    Report Date
    April 17, 2013
    Manufacturer
    CHIEN TI ENTERPRISE CO., LTD.
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE BOLTS BREAKING ON AN L-3B SCOOTER. THIS EVENT COULD COMPROMISE THE STABILITY OF THE DEVICE AND INJURY COULD OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210094 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI CHIEN TI ENTERPRISE CO., LTD. L-3B

    Patients

    Seq Age Sex Outcome Treatment
    1 50 Other