BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNG-O-JET KIT

    MDR report key: 3955246 · Received June 20, 2014

    Report

    Report Number
    2016148-2014-00001
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 11, 2014
    Product Code
    FMF
    PMA / PMN Number
    086364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, LIDOCAINE SOLUTION WAS ADMINISTERED INTO THE AIRWAY, WHILE USING A GLIDOSCOPE. WHILE THE L-O-J WAS BEING REMOVED, A 2 CENTIMETER PIECE OF PLASTIC VIAL INJECTOR BROKE OFF IN THE PATIENT'S ORAL CAVITY. MAGILLS FORCEPS WERE USED TO RETRIEVE THE BROKEN PORTION AND THE AIRWAY WAS SECURED. NO TRAUMA WAS NOTED. (B)(4) MADE SEVERAL ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION REGARDING THIS ADE FROM THE REPORTER; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363089 LARYNG-O-JET KIT FMF DJ008J3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK