BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2662538 · Received July 20, 2012

    Report

    Report Number
    1531186-2012-00574
    Date Received
    July 20, 2012
    Report Date
    July 23, 2012
    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

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR. REPORT #1531186-2012-00574 INDICATING THE MANUFACTURER AS CT MEDICAL, INC. LOCATED IN (B)(4). THE CORRECT MANUFACTURER IS C.T.M. HOMECARE PRODUCTS, INC. LOCATED IN (B)(4).

    Description of Event or Problem · 1

    DEALER ALLEGES BATTERY INDICATOR STATES FULLY CHARGE EVEN THOUGH SCOOTER HAS A VERY LOW STATIC CHARGE REMAINING." QT# (B)(4).

    Description of Event or Problem · 1

    DEALER ALLEGES BATTERY INDICATOR STATES FULLY CHARGE EVEN THOUGH SCOOTER HAS A VERY LOW STATIC CHARGE REMAINING." (B)(4).

    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-3S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other