BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER FLEX

    MDR report key: 1061847 · Received June 13, 2008

    Report

    Report Number
    MW5007320
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 13, 2008
    Manufacturer
    MALLINCKRODT, INC.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ORALLY INTUBATED WITH A 6.0 LASER FLEX CUFFED TRACHEAL TUBE WHILE SHE UNDERWENT A SAME DAY FACIAL LASER PROCEDURE. THE PROCEDURE WAS WITHOUT COMPLICATION UNTIL EXTUBATION. ATTEMPTS TO EXTUBATE WERE INITIALLY UNSUCCESSFUL AND THE PATIENT NEEDED TO BE ANESTHETIZED AND PARALYTIC AGENTS WERE UTILIZED DURING THE EXTUBATION. WATER BASED LUBRICANTS WERE USED WITH MANIPULATION TO CHANGE THE TUBE ANGLE. AFTER VARIOUS ATTEMPTS THE METAL TUBE WAS EXTRACTED. FIBER OPTIC VISUALIZATION AND DIRECT LARYNGOSCOPY WAS PERFORMED TO VISUALIZE THE VOCAL CORDS, AFT AREA AND GLOTTIS; NO INFLAMMATION, BLEEDING OR SWELLING WAS NOTED. STEROIDS WERE ADMINISTERED TO PREVENT SWELLING. PATIENT DENIED SPEAKING DIFFICULTIES, BUT DID COMPLAIN OF A SORE THROAT POST OPERATIVELY. AFTER EXTUBATION, THE METAL TRACHEAL TUBE WAS OBSERVED AS HAVING A STIFF ANGLE FORM IN THE ORO-PHARYNX/TRACHEAL PLANES WHICH COULD HAVE CONTRIBUTED TO THE DIFFICULTY IN EXTUBATION. THE PATIENT REQUIRED AN UNPLANNED HOSPITALIZATION FOR 24 HOUR OBSERVATION. THE MANUFACTURER WAS NOTIFIED OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER FLEX TRACHEAL TUBE, CUFFED BTR MALLINCKRODT, INC. NA 2005119957

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R