BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-JET

    MDR report key: 17809352 · Received September 22, 2023

    Report

    Report Number
    MW5146104
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    April 5, 2023
    Report Date
    September 20, 2023
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE BALLOON THAT HOLDS MY GJ (GASTROSTOMY-JEJUNOSTOMY) FEEDING TUBE IN PLACE POPPED AFTER ONLY BEING IN FOR 5 WEEKS. THEY TYPICALLY LAST MORE THAN 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072012 G-JET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| S