BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT G-JET

    MDR report key: 7202989 · Received January 17, 2018

    Report

    Report Number
    MW5074642
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Report Date
    January 16, 2018
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT CAME IN FOR A GJ EXCHANGE. IMAGING SHOWED THAT THE INTERNAL SPRING HAD DISLODGED FROM THE MALFUNCTIONING GJ TUBE. THE TUBE AND SPRING WERE FULLY REMOVED FROM THE PT WITH EASE. A NEW TUBE WAS INSERTED WITHOUT COMPLICATION. THIS IS THE SECOND TUBE OF THIS KIND TO HAVE THE SPRING DISLODGE IN THIS PT. BOTH TIMES THE FAMILY COMPLAINED OF REDUCED FLOW AND DIFFICULTY PUSHING FEEDS/WATER THROUGH THE J-PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42185 AMT G-JET 16F FRENCH, 3.0CM STOMAL LENGTH, 45 JEJUNAL LENGTH KNT APPLIED MEDICAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1