BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 11978606 · Received June 10, 2021

    Report

    Report Number
    3012307300-2021-05865
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 10, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312013856
    PMA / PMN Number
    K081440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT HYPERFLEX WAS LEAKING AND REQUIRED TRACH CHANGE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870023 BIVONA TRACHEOSTOMY JOH SMITHS MEDICAL ASD, INC. 75HA80 15021312013856

    Patients

    Seq Age Sex Outcome Treatment
    1