BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3130604 · Received May 24, 2013

    Report

    Report Number
    1531186-2013-02322
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH TOED-OUT WHEELS ON AN L-4R SCOOTER. THIS EVENT COULD CAUSE THE PRODUCT TO MAKE UNINTENDED AND ERRATIC MOVEMENTS AND POSSIBLY CAUSE INJURY TO USER OR BYSTANDER, OR LEAVE THE USER STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231729 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-4R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other