BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3171324 · Received June 14, 2013

    Report

    Report Number
    1531186-2013-02615
    Date Received
    June 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE MALFUNCTIONING SPEED POTENTIOMETER ON AN L-3 SCOOTER. THIS EVENT COULD CAUSE SCOOTER TO MAKE UNINTENTIONAL AND ERRATIC MOVEMENTS THAT COULD CAUSE THE USER AND BYSTANDER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271017 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other