BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT G-JET

    MDR report key: 6116491 · Received November 21, 2016

    Report

    Report Number
    6116491
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 31, 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

    AMT GJ TUBE WAS LEAKING AT ONE OF ITS PORTS. MANUFACTURER RESPONSE FOR AMT G_J TUBE, AMT GJ TUBE 14 FR 1.0CM , 15CM (PER SITE REPORTER): PROVIDING A SHIPPING LABEL FOR SHIPPING. STATED THESE DEVICES GENERALLY ARE FOR SHORT TERM 3-4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769507 AMT G-JET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. 160906-297

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES