BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3030215 · Received March 27, 2013

    Report

    Report Number
    2936999-2013-00222
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT THAT THE TUBE HAD BEEN IN USE FOR ONE WEEK AND THE CUFF DEVELOPED A LEAK AND WOULD NOT HOLD AIR. THE CALLER REPORTED THAT CUFF WOULD NOT INFLATE DURING PRETESTING. NO OTHER INFORMATION SURROUNDING CIRCUMSTANCES OF THIS REPORT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125285 SHILEY EXTENDED LENGTH TRACHESTOMY JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 201210014X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention