BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2874639 · Received December 15, 2012

    Report

    Report Number
    1531186-2012-01754
    Date Received
    December 15, 2012
    Report Date
    December 14, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE LEO-4B SCOOTER WAS RUNNING HOT, TURNING OFF WITHOUT COMMAND, AND SMELLING LIKE BURNT SMOKE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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