BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLLISTER ETAD

    MDR report key: 593741 · Received June 7, 2004

    Report

    Report Number
    1119193-2004-00003
    Event Type
    Other
    Date Received
    June 7, 2004
    Manufacturer
    HOLLISTER, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF ETAD DEVICE A PRESSURE SORE WAS NOTED BETWEEN THE NOSE AND THE LIP. PLASTIC SURGEON CONSULTED AND SKIN GRAPH MAY BE REQUIRED. THE DEVICE WAS EXAMINED AND IT WAS OBSERVED THAT THE SKIN BARRIER HAD MOVED UP THEREFORE EXPOSING THE PLASTIC TO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER ETAD ENDOTRACHEAL TUBE ATTACHMENT DEVICE BTR HOLLISTER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other