BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ENDOBRONCHIAL TUBE, ROBERTSHAW, RIGHT, 39F

    MDR report key: 2900770 · Received December 12, 2012

    Report

    Report Number
    8040412-2012-00199
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    TELEFLEX
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    COMPLAINT IS REPORTED AS: "THE SURGEON OBSERVED LEAKAGE OF GAS IN THE LUNG WHICH HE HAD BLOCKED AND AS A RESULT THE LUNG WAS SWELLED". NO PATIENT INTERVENTION OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ENDOBRONCHIAL TUBE, ROBERTSHAW, RIGHT, 39F EB TUBE JOH TELEFLEX 11KE48

    Patients

    Seq Age Sex Outcome Treatment
    1