BEUDAMED
    FDA Adverse Event Other Summary report: N

    E-TAD

    MDR report key: 491744 · Received October 23, 2003

    Report

    Report Number
    491744
    Event Type
    Other
    Date Received
    October 23, 2003
    Date of Event
    October 15, 2003
    Report Date
    October 20, 2003
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORAL ENDOTRACHEL TUBE ATTACHMENT DEVICE UTILIZED TO SECURE ETT. APPLIED APPROX. 9-10 DAYS EARLIER. WHEN THE ETT WAS ROTATED IN POSITION, THE RESPIRATORY CARE PRACTITIONER NOTICED AN ULCERATION ON THE PATIENT'S UPPER LIP. THE E-TAD WAS REMOVED AND THERE WAS ALSO AN ULCERATION ON THE PATIENT'S SKIN BETWEEN NOSE AND UPPER LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-TAD ORAL ENDOTRACHEAL TUBE ATTACHMENT DEVICE CBH HOLLISTER INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other