BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE HOLDER

    MDR report key: 517500 · Received March 15, 2004

    Report

    Report Number
    MW1031519
    Event Type
    Malfunction
    Date Received
    March 15, 2004
    Report Date
    March 15, 2004
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOLLISTER ENDOTRACHEAL HOLDER USED, RESULTED IN SKIN EROSIN ON FACE ABOVE LIP. 3CM WIDE, 1.5CM HIGH PENETRATING ORAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE HOLDER ENDOTRACHEAL TUBE HOLDER CBH HOLLISTER, INC. 9789 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other