BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRTRAQ

    MDR report key: 1351554 · Received March 23, 2009

    Report

    Report Number
    3005450700-2009-00001
    Event Type
    Other
    Date Received
    March 23, 2009
    Report Date
    March 23, 2009
    Manufacturer
    PRODOL MEDITEC S.A.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY HAD USED THE AIRTRAQ BEFORE WITHOUT ANY ISSUES, HOWEVER, UNKNOWN AS TO HOW MANY USERS HAD BEEN TRAINED AND THEIR LEVEL OF TRAINING AND PRACTICE WITH THE DEVICE. DIRECT CONTACT WAS MADE BY THE DISTRIBUTOR, (B)(4) BY LOCAL REP, MR (B)(4), ON 12/16/2008, IN WHICH HE SPOKE WITH AND PROVIDED IN-SERVICE INFORMATION TO DR (B)(6) WHO WILL BE PRESENTING IT AT A FACULTY MEETING. ADDITIONAL IN-SERVICE MATERIALS WERE PROVIDED. IT APPEARS THIS IS A USER ERROR, IN WHICH THE USER WAS TOO AGGRESSIVE DURING INSERTION CAUSING AIRWAY TRAUMA. SUCH TRAUMA HAS BEEN REPORTED WITH THE USE OF OTHER AIRWAY / INTUBATING DEVICES, I.E. GLIDESCOPE. INSTRUCTIONS FOR USE STATE THAT INSERTION SHOULD BE GENTLE.

    Description of Event or Problem · 1

    UPON INSERTION OF THE AIRTRAQ, THE TONGUE WAS LACERATED. THE FACILITY REPORTED VIA E-MAIL AND FOLLOW-UP TELEPHONE CALL THAT THEY HAD 2 INCIDENTS OCCUR WITHIN 2 WEEKS. THE PRODUCT HAS BEEN DISCARDED, AND THERE IS NO LOT INFORMATION. THE FIRST INCIDENT WAS PERFORMED BY THE ANESTHESIA TECH AND THE 2ND BY AN MD. ONE INCIDENT REQUIRED SUTURING OF THE TONGUE BY AN ENT DOC; THE OTHER CAUSED MINOR TRAUMA. IN-SERVICE INFORMATION HAS BEEN PROVIDED TO DR (B)(6) WHO WILL BE PRESENTING IT AT A FACULTY MEETING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRTRAQ RIGID LARYNGOSCOPE CCW PRODOL MEDITEC S.A. ATQ-011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention