BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE

    MDR report key: 5077323 · Received September 15, 2015

    Report

    Report Number
    5077323
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 17, 2015
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER 1 DAY IN USE, THE AMT GTUBE BUTTON BALLOON BROKE. THIS TUBE HAD PREVIOUSLY BEEN REPLACED BY THE PATIENT'S PARENTS 2 DAYS BEFORE DUE TO THAT BALLOON BUTTON BREAKING AS WELL. WE HAVE SEEN A FEW OF THESE EVENTS RECENTLY. THIS IS THE MOST CONCERNING THOUGH SINCE THE TUBE WAS ONLY 1 DAY OLD. I MET WITH OUR FIELD REP AND SHE PICKED UP THE DEFECTIVE TUBE TO RETURN IT FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609052 MINI ONE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1