BEUDAMED
    FDA Adverse Event Summary report: N

    TRACH CARE TRAY STANDARD

    MDR report key: 507668 · Received May 12, 2004

    Report

    Report Number
    9612030-2004-00001
    Date Received
    May 12, 2004
    Date of Event
    December 21, 2003
    Report Date
    December 22, 2003
    Manufacturer
    KENMEX
    Product Code
    LRQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    END OF TWILL TAPE UNRAVELED AND WORKED ITS WAY IN BETWEEN THE OUTER AND INNER TWO CANNULAE AND INTO THE TRACHEA. PT HAS MUSCULAR DYSTROPHY AND HAS HAD TRACHEOSTOMY FOR 30+ YEARS. HAD CHANGED TWILL PREVIOUS TUESDAY OR WEDNESDAY (AS USUALLY DOES APPROX TWICE A WEEK). HAD DEVELOPED A COLD AND ALSO NOTICED A SCRATCHING SENSATION IN THE BACK OF THEIR THROAT THAT PT HAD ATTRIBUTED TO THEIR COLD. PT DOES INNER CANNULA CARE ABOUT 6 TIMES A DAY WHEN PT HAS INCREASED SECRETIONS, AND PT DID LAST WEEK. WHEN PT WENT TO DO TRACH SITE CARE AND REPLACE THE TWILL PT REALIZED THAT ABOUT 6-7 INCHES OF THREAD FROM THE TWILL HAD BECOME UNRAVELED AND HAD CAUGHT BETWEEN INNER AND OUTER CANNULA, AND HAD THUS BEEN THREADED DOWN INTO THEIR TRACHEA. AS SOON AS PT REMOVED THE TWILL THE SCRATCHING SENSATION DISAPPEARED AND THEIR SECRETIONS DIMINISHED. CUSTOMER STATES THAT THE QUALITY OF THE TWILL HAS BEEN DETERIORATING FOR MANY YEARS, AND THAT PT HAS REPORTED THIS INCIDENT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH CARE TRAY STANDARD TRACH TWILL TAPE LRQ KENMEX * 315483464

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention