BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER

    MDR report key: 1760801 · Received July 13, 2010

    Report

    Report Number
    MW5016739
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    March 15, 2010
    Report Date
    July 13, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS SECUREMENT DEVICE WAS FOUND TO HAVE BECOME VERY LOOSE WHERE THE CLASP IS PRESSED DOWN TO SECURE THE FEEDING TUBE IN PLACE. THE FEEDING TUBE MIGRATED OUT OF POSITION AND THE PT ASPIRATED THE NUTRITIONAL FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER FEEDING TUBE ATTACHMENT DEVICE KNT HOLLISTER, INC. 9786

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization