BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE

    MDR report key: 20091355 · Received August 27, 2024

    Report

    Report Number
    MW5158932
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 22, 2024
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PURCHASED A NUFACE PRODUCT THAT PROMISED TO HELP WITH CONTOURING FACE DOUBLE CHIN.. WITH THYROID CANCER HISTORY I WAS HYPED ON THE PRODUCT BUT HAVE NOT BEEN ABLE TO USE IT DUE TO THE INTOLERABLE PAIN IT'S CAUSED SENDING HURTFUL SHOCKS. CAUSING BURNING SENSATION REDNESS AND RASHES ON FACE.. I'VE TRIED NUMBING CREAMS AND HAVE HAD NO LUCK AS WELL AS GELS.. I HAVE SIMILAR PRODUCTS AND THEY DO NOT CAUSE ANY PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493949 NUFACE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female