BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE NON-BALLOON BUTTON

    MDR report key: 12031695 · Received June 21, 2021

    Report

    Report Number
    12031695
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 17, 2021
    Report Date
    May 19, 2021
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OPENING COMES APART WHEN OPENING CLAMP UP TO PLACE EXTENSION G-TUBE IN PLACE. LOOKS LIKE IS HAS CRACKED APART AND LEAKING WITH FEEDS AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929571 MINI ONE NON-BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1