BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 4220540 · Received November 3, 2014

    Report

    Report Number
    1531186-2014-05293
    Date Received
    November 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    UNKNOWN
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CALLER STATES THAT THE DEVICE HAS BEEN USED FOR A TOTAL OF 10 HOURS IN 4 YEARS AND NOW THAT SHE NEEDS IT, IT IS NOT WORKING. THE UNIT LURCHES FORWARD AND THEN SUDDENLY STOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703227 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other