BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ONE® BALLOON BUTTON

    MDR report key: 19937608 · Received August 8, 2024

    Report

    Report Number
    19937608
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    June 29, 2024
    Report Date
    July 10, 2024
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    12 FR GT BALLOON DAMAGED AND LEAKING. SURGICAL TEAM TO BEDSIDE AND REPLACED GASTRONOMY TUBE (GT). FOLLOW-UP IMAGING REQUIRING TRANSPORTING PATIENT TO X-RAY FOR IMAGING STUDIES NEEDED. G-T SAVED IN BIOHAZARD BAG AND PLACED IN DEFECTIVE PRODUCT BIN. THIS IS THE SECOND INCIDENCE OF SOMETHING LIKE THIS HAPPENING FOR THIS PATIENT'S GT. MANUFACTURER RESPONSE FOR TUBES, GASTROINTESTINAL (AND ACCESSORIES), MINI ONE. BALLOON BUTTON (PER SITE REPORTER). SAMPLE RETURNED ON 7/9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398824 MINI ONE® BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1208-I

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female Hospitalization| R