BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3033970 · Received April 3, 2013

    Report

    Report Number
    1531186-2013-01397
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. END USER COULD NOT PROVIDE GREAT DETAIL AND WILL BE EMAILING IN IMAGES OF WHAT HE STATED IS BROKEN ON THE WHEELS. NO FURTHER INFORMATION AT THIS TIME. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137057 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-3X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other