BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ENDOTRACHEAL TUBE HOLDER

    MDR report key: 17334 · Received September 27, 1994

    Report

    Report Number
    17334
    Event Type
    Injury
    Date Received
    September 27, 1994
    Date of Event
    September 21, 1994
    Report Date
    September 27, 1994
    Manufacturer
    HOSPITAK, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED FULL THICKNESS LOWER LIP NECROSIS FROM ENDOTRACHEAL TUBE HOLDER. THE PT'S LOWER LIP WAS TRAPPED AGAINST THE CENTRAL PORTION OF THE TUBE RESULTING IN A T-SHAPED DEFECT. THERE WAS SO MUCH PRESSURE AGAINST THE ANTERIOR INCISOR THAT IT DROVE THE TOOTH THROUGH THE LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE ENDOTRACHEAL TUBE HOLDER ENDOTRACHEAL TUBE HOLDER BTR HOSPITAK, INC. JEAHBC B

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention CONTAMINATED.