BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAFACIAL

    MDR report key: 10206158 · Received June 26, 2020

    Report

    Report Number
    MW5095261
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 25, 2020
    Manufacturer
    HYDRAFACIAL/EDGE SYSTEMS LLC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A HYDRAFACIAL PROCEDURE DONE AND THE NEXT DAY MY FACE APPEARED REDDISH IN COLOR WITH A BREAKOUT ON MY ENTIRE FACE. I AM AFRICAN AMERICAN WITH DARK COLORED SKIN AND THE REDDISH COLOR APPEARS TO BE PERMANENT DAMAGE TO MY SKIN. DR. SHEILA BOND, A PLASTIC SURGEON SUPERVISED THE PROCEDURE BUT DID NOT DIRECTLY ADDRESS THE ADVERSE REACTIONS OF THE PROCEDURE WHEN REPORTED TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667919 HYDRAFACIAL POWERED LASER SURGICAL INSTRUMENT GEX HYDRAFACIAL/EDGE SYSTEMS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR