BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2823800 · Received October 30, 2012

    Report

    Report Number
    2936999-2012-00559
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 8, 2012
    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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE CARETAKER FOUND A LEAK IN THE PILOT LINE AT THE POINT THAT IT CONNECTS TO THE PILOT BALLOON. THE CALLER CONFIRMED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 110302355X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention