BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC CUFFED LONG

    MDR report key: 2210341 · Received August 8, 2011

    Report

    Report Number
    2936999-2011-00522
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 15, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN THEREFORE THE DATE OF MANUFACTURE CAN NOT BE DETERMINED. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR INVESTIGATION. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COVIDIEN REPRESENTATIVE IN THE UNITED KINGDOM RECEIVED A REPORT FROM THE CUSTOMER WHICH STATED: "OBTURATOR CANNOT BE EASILY PASSED OR REMOVED". IT WAS NOTED THE PATIENT REQUIRED RE-CANNULATION. NO OTHER INFORMATION WAS PROVIDED IN THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention