BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIDENT

    MDR report key: 8246052 · Received January 14, 2019

    Report

    Report Number
    1717344-2019-00088
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    November 15, 2013
    Report Date
    January 14, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    UDI-DI
    10884524001579
    PMA / PMN Number
    K011676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE MICROWAVE ABLATION OF LUNG TUMOURS: SINGLE-CENTRE PRELIMINARY EXPERIENCE SOURCE RADIOL MED. 119 (8) (75¿82), 2014. DATE OF PUBLICATION: 21 JUN 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE PERFORMED. AFTER BEING TREATED OF MICROWAVE (MW) ABLATION OF LUNG TUMORS ASYMPTOMATIC GRADE-1 PNEUMOTHORAX WAS RECORDED IN 9 PATIENTS (37.5 %). ONE CASE OF ASYMPTOMATIC PLEURAL EFFUSION AND ONE OF HAEMOPTYSIS, NOT REQUIRING TRANSFUSION, WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38875 EVIDENT SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER VTGEN 10884524001579

    Patients

    Seq Age Sex Outcome Treatment
    1