BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIVONA MEDICAL TECHNOLOGIES

    MDR report key: 370088 · Received January 3, 2002

    Report

    Report Number
    1824231-2001-00020
    Event Type
    Other
    Date Received
    January 3, 2002
    Date of Event
    November 19, 2001
    Report Date
    November 21, 2001
    Manufacturer
    BIVONA, INC
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUFF WOULD NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA MEDICAL TECHNOLOGIES TTS TRACHEOSTOMY TUBE BTO BIVONA, INC NA 1070260

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN