BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILTUBE

    MDR report key: 2800797 · Received September 26, 2012

    Report

    Report Number
    2800797
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 26, 2012
    Manufacturer
    B&B MEDICAL TECHNOLOGIES
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ET TUBE HOLDER WAS APPLIED TO THE PATIENT'S UPPER LIP AREA. THE SKIN UNDERNEATH HAD NOT BEEN ROUTINELY CHECKED. THIS RESULTED IN A MUCOUS MEMBRANE ULCER THAT WAS UNSTAGEABLE AND NECROTIC. A PLASTIC SURGERY CONSULT WAS DONE DUE TO OPEN AREA ON THE PATIENT'S UPPER LIP. THE SURGEON FOUND THAT THERE IS DENSE ESCHAR EXTENDING TRANSVERSELY ACROSS THE UPPER LIP JUST ABOVE THE VERMILION. IT IS PRIMARILY ON THE LEFT SIDE, BUT EXTENDS ACROSS THE MIDLINE. IT IS 1 CM AT ITS WIDEST POINT AND 4 CM IN LENGTH. ON THE MUCOSAL SIDE, THERE IS A SIMILAR BUT MUCH SMALLER AREA OF NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILTUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR B&B MEDICAL TECHNOLOGIES * D215801

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R