BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIVONA

    MDR report key: 574885 · Received February 18, 2005

    Report

    Report Number
    1824231-2005-00003
    Event Type
    Other
    Date Received
    February 18, 2005
    Date of Event
    January 2, 2005
    Report Date
    February 18, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CONNECT PART HAD FALLEN APART AND A NEW TUBE HAD TO BE INSERTED. NO ADVERSE OUTCOME REPORTED. PATIENT EXPERIENCED DE-SATURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA FLEXTEND TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *