BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLLOGEN LEGEND +

    MDR report key: 6365806 · Received February 28, 2017

    Report

    Report Number
    1720381-2017-00007
    Event Type
    Injury
    Date Received
    February 28, 2017
    Report Date
    April 12, 2017
    Manufacturer
    POLLOGEN LTD.
    Product Code
    GEI
    UDI-DI
    07290016586008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED BURNS AND BLISTERS TO THE LEG FOLLOWING TREATMENT WITH A POLLOGEN LEGEND + RF DEVICE. NO REPORT OF MEDICAL INTERVENTION WAS RECEIVED FROM THE USER FACILITY OTHER THAN THE INITIAL REPORT. ADDITIONALLY, THE USER FACILITY SUGGESTED THE USE OF BACITRACIN, AN OVER THE COUNTER ANTIBIOTIC OINTMENT TO THE PATIENT.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE PATIENT SUSTAINED BURNS AND BLISTERS TO THE LEG FOLLOWING TREATMENT WITH A POLLOGEN LEGEND + RF DEVICE. NO REPORT OF MEDICAL INTERVENTION WAS RECEIVED FROM THE USER FACILITY OTHER THAN THE INITIAL REPORT. ADDITIONALLY, THE USER FACILITY SUGGESTED THE USE OF BACITRACIN, AN OVER THE COUNTER ANTIBIOTIC OINTMENT TO THE PATIENT. THE LEGAL MANUFACTURER ((B)(4)) WAS NOTIFIED OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148426 POLLOGEN LEGEND + POLLOGEN LEGEND+ GEI POLLOGEN LTD. POLLOGEN LEGEND+ 07290016586008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other