BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY CUFFLESS

    MDR report key: 1924788 · Received December 8, 2010

    Report

    Report Number
    2936999-2010-01327
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    November 9, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. 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 CUSTOMER REPORTED THAT THE END OF THE INNER CANNULA WAS ROUGH AND CAUSED TRAUMA TO THE PT'S STOMA, HOWEVER, THERE WAS NO PT INJURY. THE TRACHEOSTOMY TUBE WAS REMOVED AND THE PT WAS RE-INTUBATED WITH ANOTHER UNSPECIFIED SHILEY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 0705002219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention