BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ONE NON-BALLOON BUTTON

    MDR report key: 11064661 · Received December 23, 2020

    Report

    Report Number
    11064661
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 11, 2020
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AMT GASTRIC BUTTON MALFUNCTION. THE RING THAT THE FEEDING TUBE CONNECTS INTO FELL OUT. THE PATIENT'S FATHER SUPER-GLUED THE RING BACK INTO PLACE ON SO HE COULD FEED THE PATIENT THRU THE TUBE UNTIL IT COULD BE REPLACED. THIS TUBE WAS ORIGINALLY PLACED ON (B)(6) 2020. REQUIRED A NEW PROCEDURE TO BE PERFORMED WITH ANESTHESIA TO REPLACE DEFECTIVE BUTTON TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526691 MINI ONE NON-BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-1-1417

    Patients

    Seq Age Sex Outcome Treatment
    1 1460 DA Hospitalization| R