BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3090807 · Received May 2, 2013

    Report

    Report Number
    1531186-2013-01888
    Date Received
    May 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A LEO 4-WHEEL SCOOTER, WHERE THE BATTERY INDICATOR LIGHT IS MALFUNCTIONING. THE USER WILL NOT KNOW THE ACTUAL BATTERY LEVEL AND COULD BECOME STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193028 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC LEO-4B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other