BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM TTS TRACHEOSTOMY TUBE

    MDR report key: 3800249 · Received April 30, 2014

    Report

    Report Number
    2183502-2014-00260
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ALLEGING THAT THE DEVICE WAS IN USE WITH A PATIENT WHEN THE PATIENT BECAME DISTRESSED. ACCORDING TO THE REPORTER, THE PATIENT WAS HOSPITALIZED DUE TO THE DISTRESS ON (B)(6) 2014. THE PATIENT WAS RELEASED 4 DAYS LATER ON (B)(6) 2014. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258045 BIVONA CUSTOM TTS TRACHEOSTOMY TUBE JOH- TRACHEOSTOMY TUBE JOH SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other