BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 740197 · Received July 21, 2006

    Report

    Report Number
    740197
    Event Type
    Other
    Date Received
    July 21, 2006
    Date of Event
    June 20, 2006
    Report Date
    June 27, 2006
    Manufacturer
    HOLLISTER INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON REMOVAL OF ENDOTUBE HOLDER, 3 CM AREA OF NECROSIS NOTED ON UPPER LIP. PURULENT DRAINAGE NOTED ON UPPER LIP. PLASTIC SURGERY WAS CONSULTED. WILL REQUIRE SURGERY TO REPAIR. PT INTUBATED SINCE 06. ENDOTUBE HOLDER NOTED TO BE CHANGED ONE WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ORAL ENDOTRACHEAL TUBE ATTACHMENT DEVICE BTR HOLLISTER INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other