BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER FEEDING TUBE ATTACHMENT DEVICE

    MDR report key: 1623737 · Received March 4, 2010

    Report

    Report Number
    1480288-2010-00003
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 4, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    PMA / PMN Number
    K893888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO WAS PROVIDED. PT WAS REPORTED TO HAVE DIED FROM UNRELATED CAUSES. THE USER FACILITY REPORTED THAT IF THE PT HAD NOT DIED, PLASTIC SURGERY WOULD HAVE BEEN REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THE FEEDING TUBE ATTACHMENT DEVICE (FTAD) IN PLACE ON HIS NOSE FOR TWO DAYS. A PRESSURE NECROSIS DEVELOPED ON THE NOSE (NASAL NARE) UNDER THE SECTION OF THE DEVICE WHERE THE RIGID TUBE CLIP IS ATTACHED. THE USER FACILITY STATED THAT THEY BELIEVE THE FTAD WAS APPLIED TOO HIGH ON THE PT'S NOSE WHICH RESULTED IN THE INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other