BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENOVA WITH NEUTROX HYPOCHLOROUS ACID 0.01 PERCENT

    MDR report key: 5913404 · Received August 25, 2016

    Report

    Report Number
    MW5064431
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    July 15, 2016
    Report Date
    August 18, 2016
    Manufacturer
    NOVA BAY PHARMACEUTICALS INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I FOLLOWED DIRECTIONS EXACTLY AS GIVEN ON BOX AND DIRECTION PAPER. SHORTLY AFTER APPLICATION ON LIPS I BEGAN TO FEEL DULL SORENESS AND IRRITATION. IT CONTINUED UNTIL LATE IN THE EARLY MORNING. THE SORENESS BECAME MORE SEVERE THE FOLLOWING MORNING. I COULD NOT READ OR WATCH TV. THE IRRITATION CONTINUED FOR THE NEXT TWO AND A HALF WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554697 AVENOVA WITH NEUTROX HYPOCHLOROUS ACID 0.01 PERCENT AVENOVA WITH NEUTROX HYPOCHLOROUS ACID 0.01 PERCENT FRO NOVA BAY PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1