BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3042079 · Received April 3, 2013

    Report

    Report Number
    2936999-2013-00250
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    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 RECEIVED A CALL THIS MORNING FROM THEIR CHARGE NURSE NOTICED IN THIS PARTICULAR SIZE THAT 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 EVENTS OF THIS REPORT; HOWEVER, THE CALLER REPORTED THAT THEY SCHEDULED REPLACEMENT FROM ETT TO TRACHEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136664 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention