BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ONE BALLOON BUTTON

    MDR report key: 4905783 · Received July 3, 2015

    Report

    Report Number
    MW5043927
    Event Type
    Injury
    Date Received
    July 3, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 3, 2015
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY CHILD HAS HAD A G-TUBE FOR ALMOST 5 YEARS. WE HAVE ALWAYS USED THE MINI ONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE. FOR ALMOST 4.5 YEARS, WE NEVER HAD A PROBLEM WITH THE STOMA SITE. EVER SINCE THE MANUFACTURER CHANGED THE BUTTON TO MAKE IT GLOW IN THE DARK, WE HAVE HAD 2 STOMA SITE INFECTIONS. THE GLOW IN THE DARK ASPECT OF THE BUTTON MUST BE CAUSING SENSITIVITY ISSUES AND IS RESULTING IN INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434013 MINI ONE BALLOON BUTTON FEEDING TUBE FPD APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1412

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention