BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER E.TAD

    MDR report key: 1669488 · Received February 18, 2010

    Report

    Report Number
    1669488
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 17, 2010
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT INTUBATED FOR EXTENDED TIME ETAD USED. WHEN REMOVED ETAD IN ORDER TO RE-INTUBATE, DONE SLOWLY: REVEALED 2 PRESSURE ULCERS WITH ONE CHEEK UNSTAGEABLE, AND THE OTHER CHEEK STAGE 2. THE ULCERS WERE UNDER THE BARRIERS ADHERING THE DEVICE TO THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER E.TAD E.TAD; ORAL ET TUBE ATTACHMENT DEVICE CBH HOLLISTER, INC. 9799

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other ET TUBE