BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2862720 · Received December 10, 2012

    Report

    Report Number
    1531186-2012-01650
    Date Received
    December 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CONSUMER, HER SCOOTER RANDOMLY TURNS ON AND OFF, AND THE LIGHTS ON THE TILLER WHICH INDICATE WHETHER OR NOT IF IT'S ON OR NOT, TURN ON AND OFF. SHE FURTHER STATES THAT WHEN SHE IS GOING UP INCLINES, IT TURNS OFF. MDR FILED.

    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 L-3B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other