BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIC TRACH TUBE

    MDR report key: 706422 · Received August 25, 2005

    Report

    Report Number
    1217052-2005-00074
    Event Type
    Malfunction
    Date Received
    August 25, 2005
    Date of Event
    July 1, 2005
    Report Date
    July 27, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS CUFF LEAKAGE AFTER THE TRACHEOSTOMY TUBE WAS IN PLACE FOR SIX WEEKS. NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIC TRACH TUBE TRACHEOSTOMY TUBE BTO SMITHS MEDICAL ASD, INC. NA K507084

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO