BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE TRINITY FACIAL TONING DEVICE

    MDR report key: 14105061 · Received April 12, 2022

    Report

    Report Number
    MW5108954
    Event Type
    Injury
    Date Received
    April 12, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 8, 2022
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED DEVICE ON HIGHEST LEVEL CONSISTENT WITH INSTRUCTIONS AND INSTRUCTIONAL VIDEOS BY NUFACE AND ITS ENDORSERS. AVOIDED THYROID AS INSTRUCTED. SUDDEN ONSET OF ITCHING ALONG JAW LINE AND NECK, CENTRALIZING IN SKIN ABOVE THYROID. THYROID SKIN BECAME STRIATED AND INCREDIBLY ITCHY. ACCOMPANIED BY RACING HEART, HEART PALPITATIONS, INFLAMMATION OF NECK LYMPH NODES, GENERAL EXHAUSTION AND NAUSEA, CONGESTION AND INFLAMMATION, LEFT EYE PAIN. EVENTUALLY, ITCHINESS SUBSIDED AND THYROID BECAME INFLAMED AND FELT AS IF SWALLOWING OVER SOMETHING. MET WITH PCP, WHO ORDERED ROUND OF BLOODWORK AND THYROID ULTRASOUND. BLOODWORK INDICATED NORMAL TSH AND T3 NUMBERS. THYROID ULTRASOUND INDICATED HYPERVASCULAR THYROID GLAND SUGGESTING SUDDEN ONSET OF THYROIDITIS. THE ONLY NEW ACTIVITY IN MY LIFE WAS NUFACE. NO NEW BODY CARE, DERMATOLOGICAL TREATMENTS, EXTERNAL STRESSORS, OR OTHERWISE. OTHER BLOODWORK AND BLOOD COUNT NORMAL. DEVICE RETURNED TO NUFACE (ORDER NO. (B)(4)) AND REPORTED ADVERSE EVENT (COMPLAINT NO. (B)(4)). I DO NOT BELIEVE THIS DEVICE SHOULD BE APPROVED FOR USE ON NECK AT ALL GIVEN THESE RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786914 NUFACE TRINITY FACIAL TONING DEVICE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other FISH OIL| GLUCOSAMINE. ALL TAKEN FOR OVER 1.5 YEARS BEFORE USE OF NUFACE DEVICE. NOT CHANGED AT TIME OF USAGE.| LO-OVAL BIRTH CONTROL| MULTIVITAMIN| PROBIOTIC