BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2077709 · Received April 20, 2011

    Report

    Report Number
    2936999-2011-00298
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 25, 2011
    Manufacturer
    COVIDIEN (FORMERLY TYCOHEALTH)
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # 112-70 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR U.S. DISTRIBUTED PART IS K871204. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION 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 REC'D A REPORT WHERE IT WAS CLAIMED THAT THE CUFF DEVELOPED A LEAK DURING PT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE BTR COVIDIEN (FORMERLY TYCOHEALTH)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention