BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 1828185 · Received September 1, 2010

    Report

    Report Number
    2936999-2010-01160
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 2, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPLICABLE 510K# FOR U.S DISTRIBUTED PART IS K884730. THE SAMPLE ASSOCIATED TO THIS REPORT IS NOT EXPECTED TO BE RETURNED. THE CUSTOMER HAS CONFIRMED THERE IS NO DEFICIENCY WITH THE PRODUCT, BUT DUE TO VISUAL OBSERVATION OF UNSPECIFIED ARTEFACTS DURING THE MRT PROCEDURE, THE END PHYSICIAN ELECTED TO REMOVE THE TUBE AND PERFORM MRT WITH A UNSPECIFIED REPLACEMENT TUBE. IF ANY NEW OR SIGNIFICANT INFO BECOMES AVAILABLE RELATED TO THIS REPORT, A SUMMARY WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT THAT USE OF THE TUBE FOR A CERVICAL SPINE MRT (MAGNETIC RESONANCE TOMOGRAPHY) REVEALED UNSPECIFIED ARTIFACTS IN THE PATIENT'S CERVICAL SPINAL AREA. THERE IS NO DEFICIENCY BEING REPORTED AGAINST THE TUBE, BUT DUE TO VISUAL OBSERVATION OF UNK ARTIFACTS, THE END PHYSICIAN ELECTED TO REMOVE THE TUBE AND PERFORM THE MRT WITH ANOTHER TUBE. THE CUSTOMER NOTED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PERCUTANEOUS TRACHEOSTOMY BTO COVIDIEN, FORMERLY TYCO HEALTHCARE 2010027955

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention