BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVAREE

    MDR report key: 11841565 · Received May 17, 2021

    Report

    Report Number
    MW5101387
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BONAFIDE / JDS THERAPEUTICS LLC / FARMA-DERMA S.R.L.
    Product Code
    NUC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I STARTED USING REVAREE BY BONAFIDE IN (B)(6) 2020. I USED THE PRODUCT AS DIRECTED, EVERY 2-3 DAYS, AT BEDTIME. I USED THE PRODUCT FOR A FEW MONTHS BUT EXPERIENCED BURNING SO I DISCONTINUED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735012 REVAREE LUBRICANT, PERSONAL NUC BONAFIDE / JDS THERAPEUTICS LLC / FARMA-DERMA S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR