BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK MIC-KGY

    MDR report key: 576486 · Received February 24, 2005

    Report

    Report Number
    MW1034740
    Event Type
    Malfunction
    Date Received
    February 24, 2005
    Date of Event
    January 31, 2005
    Report Date
    February 24, 2005
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE GASTROSTOMY BUTTON WAS LEAKING FORMULA AROUND THE SITE. THE BALLOON WAS CHECKED FOR INFLATION AND THE FORMULA WAS REMOVED FROM THE BALLOON. WHEN THE DEVICE WAS REMOVED, A HOLE WAS FOUND IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK MIC-KGY GASTROSTOMY FEEDING TUBE KNT BALLARD MEDICAL PRODUCTS REF 0120-14-1.2 279914

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other