BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIC TRACHEOSTOMY TUBE

    MDR report key: 266729 · Received March 3, 2000

    Report

    Report Number
    1217052-2000-00009
    Event Type
    Malfunction
    Date Received
    March 3, 2000
    Date of Event
    January 1, 2000
    Report Date
    February 2, 2000
    Manufacturer
    SIMS PORTEX, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    A HOME CARE PT ALLEGES THAT A LEAK DEVELOPED AT THE TRACHEOSTOMY TUBE'S INFLATION LINE AFTER 2 WEEKS USE. THE TUBE WAS REPLACED AND THERE WAS NO PT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIC TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE AND TUBE CUFF BTO SIMS PORTEX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO