BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA FENESTRATED

    MDR report key: 1990975 · Received February 10, 2011

    Report

    Report Number
    2936999-2011-00035
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 11, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RETURNED A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER STATED THE TRACHEOSTOMY TUBE WAS LEAKING WITHIN A WEEK OF INTUBATION. THE PATIENT WAS RE CANNULATED WITH ANOTHER TRACHEOSTOMY TUBE AFTER ABOUT A WEEK. THE CALLER COULD NOT TELL WHERE THE LEAK WAS AND WHEN HE SQUEEZES THE CUFF, THE AIR DOES GO OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1005000881

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention