BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2864350 · Received December 5, 2012

    Report

    Report Number
    2936999-2012-00587
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT AFTER ABOUT SIXTEEN TO SEVENTEEN DAYS PATIENT USE, THE CUFF DEVELOPED A LEAK. THE CALLER CONFIRMED THAT EXTUBATION AND RECANNULATION OF REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SPECIALIZED TRACHEOSTOMY JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 1204001076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention