BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLLOGEN LEGEND +

    MDR report key: 6365713 · Received February 28, 2017

    Report

    Report Number
    1720381-2017-00008
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    January 30, 2017
    Report Date
    February 28, 2017
    Manufacturer
    POLLOGEN LTD.
    Product Code
    GEI
    UDI-DI
    07290016586008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED AN UNTYPICAL REACTION OF UNKNOWN SEVERITY FOLLOWING TREATMENT WITH A POLLOGEN LEGEND+ RF DEVICE. NO REPORT OF MEDICAL INTERVENTION WAS RECEIVED FROM THE USER FACILITY OTHER THAN THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148064 POLLOGEN LEGEND + POLLOGEN LEGEND+ GEI POLLOGEN LTD. POLLOGEN LEGEND+ 07290016586008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other