BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED

    MDR report key: 1884039 · Received October 13, 2010

    Report

    Report Number
    2936999-2010-01200
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 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
    FR
    Reporter Occupation
    NOT APPLICABLE

    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. NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE.

    Description of Event or Problem · 1

    THE COVIDIEN REPRESENTATIVE IN FRANCE RECEIVED A REPORT FROM A CUSTOMER THAT STATED: "THE INTERNAL CANNULA IS TURNING FREELY INSIDE THE EXTERNAL CANNULA AFTER A FEW DAYS AND COMES OUT SPONTANEOUSLY OF THE EXTERNAL CANNULA." THE PATIENT REQUIRED A NON-ROUTINE REPLACEMENT OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN / FORMERLY TYCO HEALTHCARE 1001001507

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention