BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM TRACHEOSTOMY TUBE

    MDR report key: 1920525 · Received December 6, 2010

    Report

    Report Number
    2183502-2010-00563
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.,
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 1 WEEK IN SITU. AN EMERGENT REPLACEMENT WAS REQUIRED. NO FURTHER INCIDENT RELATED 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other