BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 4173844 · Received October 15, 2014

    Report

    Report Number
    1525712-2014-06984
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    UNKNOWN
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGED THAT THE AXLE SHAFT IS CROSS THREADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655637 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other