BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3064791 · Received April 17, 2013

    Report

    Report Number
    1531186-2013-01623
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    CT MEDICAL, INC.
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AN INVACARE REPRESENTATIVE REPORTED THAT THE FRAME OF THE SCOOTER IS BENT. THIS ISSUE MAY COMPROMISE THE OPERATION OF THE UNIT AND CREATE THE POTENTIAL FOR INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164251 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI CT MEDICAL, INC. L-3B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other