BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI CLASSIC BUTTON

    MDR report key: 11874574 · Received May 25, 2021

    Report

    Report Number
    11874574
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 21, 2021
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    G-TUBE PLACED VIA SURGERY- ONE-WEEK POST PLACEMENT PATIENT SEEN IN ED WITH QUESTIONABLE NON-FUNCTIONING G-TUBE. UPON REMOVAL AND PLACEMENT, HOLE NOTED IN BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777402 MINI CLASSIC BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1