BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIONE BALLOON BUTTON

    MDR report key: 23801862 · Received December 15, 2025

    Report

    Report Number
    1526012-2025-00019
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 15, 2025
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071140359
    PMA / PMN Number
    K161413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A RESPONSE TO MEDSUN REPORT # (B)(4), WHICH WAS RECEIVED BY AMT FROM THE FDA ON 11/18/2025. THE OCCURRENCE WAS ORIGINALLY REPORTED TO AMT ON 10/23/2025 BY THE SAME INITIAL REPORTER. THE COMPLAINT WAS REPORTED FOR A M1-5-1208-I DEVICE WITH THE PARTIAL LOT NUMBER '250214-54'. AMT WORKED WITH THE ORIGINAL REPORTER TO OBTAIN THE DEVICE FOR EXAMINATION AND PERFORMED AN INSPECTION OF THE DEVICE ONCE RETURNED. EXAMINATION FOUND THE USER FACILITY RETURNED A M1-5-1210-I DEVICE FOR THE COMPLAINT. REVIEW OF PRODUCTION RECORDS TRACED THE PARTIAL LOT NUMBER TO LOT '250214-549' WHICH IS A M1-5-1210-I LOT, CONFIRMING THE PART SIZE WAS ORIGINALLY MISREPORTED. EXAMINATION OF THE DEVICE WAS ABLE TO CONFIRM THE REPORTED COMPLAINT THAT THE BALLOON HAD FAILED. RECENT TRENDING DATA SHOWS NO ANOMALIES IN REPORTED FAILURES FROM THE FIELD. THE COMPLAINT INFORMATION HAS BEEN LOGGED INTO OUR COMPLAINT DATABASE FOR TRENDING PURPOSES. INFORMATION REGARDING DEVICE INVESTIGATION CAN BE FOUND UNDER COMPLAINT # (B)(4). BASED ON THE PROVIDED INFORMATION, THE COMPLAINT IS NOT A REPORTABLE EVENT PER 21 CFR SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. THEREFORE, THE COMPLAINT IS NOT REPORTABLE.

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER IN MEDSUN REPORT #: (B)(4), IT WAS REPORTED THAT THE "RN CARING FOR PATIENT REPORTED THAT THE GT [GASTRIC TUBE] WAS LEAKING AND THEN FELL OUT, SHOWING THAT THE BALLOON WAS PUNCTURED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789387 MINIONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1210-I 250214-549 00842071140359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female