BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNG-O-JET 160 MG 4 ML

    MDR report key: 3803011 · Received May 5, 2014

    Report

    Report Number
    MW5035957
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 2, 2014
    Manufacturer
    INTERNATIONAL MEDICATION SYSTEMS, LTD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LIDOCAINE HCL TOPICAL SOLUTION (LARYNG-O-JET) INTO AIRWAY WHILE USING GLIDOSCOPE. WHEN LARYNG-O-JET WAS REMOVED A 2CM PIECE OF PLASTIC VIAL INJECTOR BROKE OFF IN THE PT'S ORAL CAVITY. AIRWAY WAS SECURED. MAGILLS FORCEPS WERE USED TO RETRIEVE THE BROKEN PORTION OUT OF AWAY. NO TRAUMA NOTED. REASON FOR USE: SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267893 LARYNG-O-JET 160 MG 4 ML LARYNG-O-JET KIT FMF INTERNATIONAL MEDICATION SYSTEMS, LTD 6300 DJ008J3

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention