BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRULITE

    MDR report key: 8546304 · Received April 23, 2019

    Report

    Report Number
    MW5086121
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 21, 2019
    Manufacturer
    VIRULITE LLC
    Product Code
    OKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THE VIRULITE DEVICE AS INSTRUCTED ON MY UPPER LIP TWICE ON (B)(6) 2019 AT ABOUT 9AM AND 7PM. I WOKE THE NEXT DAY WITH SEVERE BURN FROM THE BOTTOM OF MY NOSE TO THE TOP OF MY LIP. MY COLD SORE HAD SPREAD ACROSS MY TOP LIP AND TO MY BOTTOM LIP. THE BURN EXTENDED INTO MY RIGHT NOSTRIL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335314 VIRULITE LIGHT BASED TREATMENT FOR COLD SORES HERPES SIMPLEX VIRUS-1 OKJ VIRULITE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other