BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT G-JET

    MDR report key: 6116492 · Received November 21, 2016

    Report

    Report Number
    6116492
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 3, 2016
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEAKING AMT G-J TUBE WHEN IN USE AT ONE OF THE PORTS. PORT VALVE NOT IN PLACE OR INCOMPETENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768545 AMT G-JET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. 15121650

    Patients

    Seq Age Sex Outcome Treatment
    1