BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2890565 · Received December 20, 2012

    Report

    Report Number
    2936999-2012-00697
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER STATED, HER CUSTOMER NOTED THAT THEY HAD CUFF LEAKS ON THE TUBE. THE CUFF CALLER REPORTED, THE CUFF APPEARED TO BLOW. THE CALLER REPORTED THIS OCCURRED ON FOUR TUBES DURING USE ON ONE PT. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY EXTENDED LENGTH TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 201201167X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention