BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3821598 · Received May 20, 2014

    Report

    Report Number
    1531186-2014-01849
    Date Received
    May 20, 2014
    Report Date
    April 7, 2014
    Manufacturer
    C.T.M. TAIWAN
    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

    PROVIDER ALLEGES THE WHEEL RETAINING RING KEEPS COMING OFF MAKING WHEEL HIT FENDER AND CAUSING INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300405 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. TAIWAN PEGASUS4R-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other