BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONICS/XOMED

    MDR report key: 1613721 · Received March 17, 2010

    Report

    Report Number
    MW5014861
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 17, 2010
    Manufacturer
    MEDTRONIC XOMED
    Product Code
    BSK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B) (6) FEMALE CAME TO OUR FACILITY FOR HER THIRD LARYNGOSCOPY WITH LASERING OF STENOSIS. A LASER-SHIELD 11 - MEDTRONICS/XOMED- WAS INSERTED VIA TRACHEOSTOMY, CRNA CONFIRMS THAT THE CUFF WAS TESTED AND WAS PATENT, SURGEON BEGAN LASERING AND NOTICED A CHARRING AROUND THE TUBE, HE IMMEDIATELY REMOVED THE TUBE, THE TUBE THEN BECAME ENGULFED WITH FLAMES, THE PATIENT SUFFERED TRACHEAL BURNS, SHE WAS TRANSFERRED TO ICU AND IS EXPECTED TO BE DISCHARGED (B) (6) 2010. THE CRNA DID ACKNOWLEDGE SHE DID NOT TURN DOWN HER FIO2, HOWEVER, WE ARE NOT RULING OUT THE POSSIBILITY OF A DEFECTIVE LASER TUBE/CUFF WHICH IS WHY WE ARE SENDING IT BACK TO THE MANUFACTURER. DIAGNOSIS OR REASON FOR USE: INTUBATION, LASER BEING USED. EVENT REAPPEARED AFTER REINTRODUCTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS/XOMED LASER-SHIELD 11 TUBE BSK MEDTRONIC XOMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization