BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1910709 · Received November 22, 2010

    Report

    Report Number
    2936999-2010-01341
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K051416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION. WITHOUT THE ACTUAL COMPLAINT SAMPLES BEING RETURNED AND THE LOT NUMBER OF THE PRODUCT, A FULL INVESTIGATION CANNOT BE CARRIED OUT. A SAMPLE IS BEING RETURNED ON THE ASSOCIATED REPORT. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT OF A LEAK, BUT THE SOURCE OF THE LEAK COULD NOT BE IDENTIFIED AND RESULTED IN DIFFICULTY IN INFLATING AND/OR DEFLATING THE CUFF. THIS REPORT IS ASSOCIATED TO THE SECOND OCCURRENCE REFERENCED ON MFR# 2936999-2010-01340 / (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT SHILEY TRACHEOSOFT XLT EXTENDED LEN JOH COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention