BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2113415 · Received May 26, 2011

    Report

    Report Number
    2936999-2011-00352
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 28, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 138-80 IS NOT DISTRIBUTED IN THE U.S; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K871204. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT "THE CUFF BROKE" DURING PT USE. THE CALLER REPORTED THIS OCCURRED ON TWO TUBES ON THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 2010059763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention