BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE

    MDR report key: 4102647 · Received September 10, 2014

    Report

    Report Number
    2183502-2014-00657
    Event Type
    Injury
    Date Received
    September 10, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOME AVAILABLE AND IS RETURNED AND EVALUATION, THE MANUFACTURER WILL FILE A FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT A LEAK WAS FOUND IN THE TRACHEOSTOMY TUBE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN USE. THE TRACHEOSTOMY TUBE REQUIRED AND UNSCHEDULED CHANGE. NO PERMANENT ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559507 PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL MD, INC. NA CS015970

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention