BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT BULLARD ELITE BLADE EXTENDER

    MDR report key: 555747 · Received September 20, 2004

    Report

    Report Number
    555747
    Event Type
    Other
    Date Received
    September 20, 2004
    Date of Event
    September 9, 2004
    Report Date
    September 20, 2004
    Manufacturer
    ACMI CORPORATION
    Product Code
    CCW
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTENDING ANESTHESIOLOGIST USING ADULT BULLARD ELITE LARYNGOSCOPE. IT IS AN EXTENSION WHICH IS SUPPLIED TO MAKE THE DEVICE MORE EFFECTIVE IN VISUALIZING THE LARYNX FOR ENDOTRACHEAL INTUBATION. PHYSICIAN BELIEVES DEVICE WAS BEING USED PROPERLY. THE PLASTIC TIP SOME HOW MUST HAVE BECOME DISLODGED AND WASN'T NOTICED BY THE STAFF. PATIENT COMPLAINED OF SORE THROAT AFTER THE PROCEDURE. GIVEN THROAT SPRAY, ETC. PATIENT WAS LATER GIVEN MEDICATIONS AND BEGAN TO CHOKE AND COUGHED UP 1 X 3 INCH PIECE OF PLASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BULLARD ELITE BLADE EXTENDER LARYNGOSCOPE BLADE EXTENDER CCW ACMI CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR