BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3255127 · Received July 30, 2013

    Report

    Report Number
    1531186-2013-03495
    Date Received
    July 30, 2013
    Report Date
    July 15, 2013
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR. REPORT # 1531186-2013-03495 INDICTING THE MANUFACTURER AS CHIEN TI ENTERPRISES CO., LTD WHEN IN FACT THE CORRECT MANUFACTURER IS C.T.M. HOMECARE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A L-3B SCOOTER HAD AN UNKNOWN MALFUNCTION CAUSING THE USER TO GET A SMALL SPLIT IN HER ELBOW (1/2-3/4 IN). ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355681 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 Required Intervention