BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-JET

    MDR report key: 4286065 · Received November 17, 2014

    Report

    Report Number
    4286065
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 17, 2014
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS GJ TUBE WAS PLACED WITHOUT DIFFICULTY 18 DAYS PRIOR TO THE EVENT. A NEW TUBE WAS PLACED BECAUSE THE ORIGINAL TUBE WAS FOUND TO HAVE A HOLE IN IT AND COULD NO LONGER BE USED TO DELIVER THERAPY. NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741937 G-JET TUBE, GASTROINTESTINAL KNT APPLIED MEDICAL TECHNOLOGY INC UNK 14011313

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO