BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDALL

    MDR report key: 420008 · Received September 23, 2002

    Report

    Report Number
    9612030-2002-00009
    Event Type
    Other
    Date Received
    September 23, 2002
    Date of Event
    August 12, 2002
    Report Date
    September 19, 2002
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    EPE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCOHEALTHCARE/KENDALL ON 9/13/02 THAT A CUSTOMER HAD A PROBLEM WITH A TRACH BRUSH. THE CUSTOMER STATES THAT THE PATIENT WAS USING THE TRACH CLEANING BRUSH IN THE KIT TO CLEAR THE INNER CANNULA WHILE THE TRACH TUBE WAS STILL IN THE PATIENT. THE PATIENT INSERTED THE BRUSH AND LOST THE BRUSH DOWN THE TRACHEA. THE PATIENT REQUIRED SURGERY FOR REMOVAL OF THE CLEANING BRUSH FROM THE LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL BASIC TRACH CARE SET EPE TYCO HEALTHCARE/KENDALL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other