BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 2964138 · Received February 11, 2013

    Report

    Report Number
    2936999-2013-00081
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE REPORTER HAS INFORMED COVIDIEN THAT THE SAMPLE WILL NOT BE MADE AVAILABLE FOR ANALYSIS. EFFORTS TO COLLECT FURTHER INFO ARE ONGOING FROM COVIDIEN.

    Description of Event or Problem · 1

    THE CALLER, REP OF RESPIRATORY THERAPY REPORTED THAT THE CUFF ON THE REPORTED TUBE WAS NOT HOLDING AIR AND APPEARED TO BE LEAKING. THE CALLER REPORTED THAT THE PT WAS DECANNULATED AND RECANNULATED WITH A COMPETITIVE DEVICE. THE CALLER STATED COMPLICATIONS ENSUED DURING THE CANNULATION PROCESS AND THE PT EVENTUALLY EXPIRED. COVIDIEN HAS MADE MULTIPLE ATTEMPTS TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60008 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 12H1015JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death