BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE

    MDR report key: 17079826 · Received June 6, 2023

    Report

    Report Number
    MW5118233
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 2, 2023
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A FACIAL ON TUESDAY (B)(6) 2023 AND THE TECHNICIAN ASKED ABOUT AN ADDITIONAL SERVICE USING THE NUFACE DEVICE. WE PROCEEDED AND I DID FEEL TINGLING AND A BURNING SENSATION AS SHE USED THE DEVICE ON ME. SHE SAID THAT WAS NORMAL. THURSDAY (B)(6) I NOTICED A VISIBLE DEEP INDENTION ON ONE SIDE OF MY FACE FROM THE BASE OF MY NOSE THAT LEADS UP TO MY EYE. I CONTACTED THE PROVIDER AND AWAITING A RESPONSE. I ALSO HAVE CONTACTED NUFACE VIA EMAIL AND ALSO AWAITING A REPLY. I AM TRYING TO FIND THE DATA THAT WAS SUBMITTED TO THE FDA THAT SHOWS ADVERSE EVENTS AND ALERT THE FDA TO THIS CONCERN. ONLINE I HAVE FOUND SOME INSTANCE OF INDENTIONS FROM PEOPLE THAT HAVE USED THE DEVICE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957158 NUFACE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other