BEUDAMED
    FDA Adverse Event Other Summary report: N

    BULLARD

    MDR report key: 515460 · Received March 8, 2004

    Report

    Report Number
    515460
    Event Type
    Other
    Date Received
    March 8, 2004
    Date of Event
    January 1, 2004
    Report Date
    February 1, 2004
    Manufacturer
    ACMI CORP
    Product Code
    EQN
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT COMPLAINED OF A SORE THROAT AFTER A SURGICAL PROCEDURE THAT INCLUDED THE USE OF AN ACMI BULLARD LARS-A LARYNGOSCOPE. EXAMINATION OF THE PT REVEALED THAT A PLASTIC LARYNGOSCOPE BLADE EXTENDER HAD BEEN LEFT WITHIN THE PT WHEN THE LARYNGOSCOPE WAS REMOVED. CLOSE EXAMINATION OF THE LARYNGOSCOPE REVEALED THAT THE PLASTIC EXTENDER CAN BE DIFFICULT TO ATTACH AND IF NOT PROPERLY ATTACHED, CAN UNINTENTIONALLY BECOME DISCONNECTED FROM THE DEVICE. ANESTHESIOLOGISTS INVESTIGATING THE INCIDENT INDICATED AN AWARENESS OF THIS PROBLEM HAVING OCCURRED BEFORE, BOTH AT THIS INSTITUTION AND ELSEWHERE. THIS DEVICE IS STILL IN USE AT THE FACILITY AND THEY WILL CONTACT THE MFR, AT THE REQUEST OF THE FDA, TO COME ON SITE AND EVALUATE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BULLARD LARYNGOSCOPE WITH DISPOSABLE EXTENDER EQN ACMI CORP ADULT BULLARD ELITE WITH INTRODUCING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other