BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIVONA

    MDR report key: 525211 · Received May 12, 2004

    Report

    Report Number
    1824231-2004-00005
    Event Type
    Other
    Date Received
    May 12, 2004
    Report Date
    May 11, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TUBE WAS INSERTED INTO THE PT AND THEY THINK IT TWISTED, THE TUBE FLIPPED UPWARD. THE PT WAS IN SEVERE DISTRESS BUT IT WAS NOT NOTICED FOR A COUPLE DAYS THAT THE FLANGE WINGS WERE DOWNWARD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other