BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3042296 · Received April 3, 2013

    Report

    Report Number
    2936999-2013-00249
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTH
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THAT SHE REC'D A CALL THIS MORNING FROM THEIR CHARGE NURSE, AND IT WAS REPORTED THAT IN THE LAST TWO MONTHS THEY HAVE NOTICED IN THIS PARTICULAR SIZE, THAT ALL PTS THAT HAVE THIS SIZE TUBE IN, THE PT IS DEVELOPING EDEMA; WHEN THEY REMOVE THE TUBE. THE CALLER REPORTED THE EDEMA DISAPPEARS QUICKLY. COVIDIEN IS ATTEMPTING TO COLLECT FURTHER DETAILS RELATED TO THE CIRCUMSTANCES SURROUNDING THE EVENT OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137373 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN, FORMERLY TYCOHEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other