BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYLFIRM X

    MDR report key: 17119609 · Received June 13, 2023

    Report

    Report Number
    MW5118363
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    August 24, 2022
    Report Date
    June 9, 2023
    Manufacturer
    BENEV / VIOL CO., LTD.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD SYLFIRM X TREATMENT AT (B)(6) A MEDICAL SPA IN (B)(6). THE MEDSPA SOLD THIS PROCEDURE AS SHRINKING PORES AND ERASE WRINKLES ALONG WITH MANY CLAIMS NOT SUBSTANTIATED BY THE FDA. I TRUSTED THE MEDSPA AND WENT AHEAD WITH THE PROCEDURE. IT HAD BADLY DAMAGED MY SKIN TEXTURE, I WAS NOT ABLE TO WORK FOR MANY MONTHS DUE TO THE INTENSE STRESS CAUSED BY THE FACIAL DAMAGE. MY FACE WAS BADLY SCARRED, AND I LOST SIGNIFICANT AMOUNT OF FACIAL FAT. WHEN I REACHED OUT TO SYLFIRMX COMPANY VIA SOCIAL MEDIA THEY IMMEDIATELY BLOCKED ME. IT HAS BEEN OVER NINE MONTHS, MY DAMAGE IS PERMANENT AND HAS COMPLETELY DERAILED MY LIFE, I CANNOT ACCEPT MY FACIAL DISFIGURATION AND I DON'T WANT TO LIVE ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252629 SYLFIRM X ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BENEV / VIOL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other