BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA MEDICAL TECHNOLOGIES

    MDR report key: 437248 · Received January 6, 2003

    Report

    Report Number
    1824231-2002-00009
    Event Type
    Malfunction
    Date Received
    January 6, 2003
    Report Date
    January 3, 2003
    Manufacturer
    PORTEX, INC.
    Product Code
    BTO
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT COUGHED UP A PIECE OF MATERIAL THAT LOOKED LIKE CUFF MATERIAL, HOWEVER THE CUFF ON THE TRACH TUBE IS WHOLE. PT WAS IN ICU AT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA MEDICAL TECHNOLOGIES 9.5 ADULT TTS TRACHEOSTOMY TUBE BTO PORTEX, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *