BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1870847 · Received October 6, 2010

    Report

    Report Number
    2936999-2010-01251
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 10, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K791045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 317-90 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K# FOR UNITED STATES DISTRIBUTED PART IS K791045. 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 RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE PILOT BALLOON DEFLATED DURING PATIENT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE WITH LANZ BTR COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention