BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM TRACHEOSTOMY TUBE

    MDR report key: 1861930 · Received October 4, 2010

    Report

    Report Number
    2183502-2010-00428
    Event Type
    Injury
    Date Received
    October 4, 2010
    Report Date
    October 1, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE REQUIRED REMOVAL AND WAS REPLACED WITH ANOTHER TRACH TUBE. IT IS ALLEGED THAT AFTER ONE DAY IN SITU, THE SUSPECT MEDICAL DEVICE CAUSED THE TISSUE TO BLEED. AFTER REPLACEMENT, NO FURTHER MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOM TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA CL79962

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention