BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE MINI+

    MDR report key: 21987450 · Received May 8, 2025

    Report

    Report Number
    MW5170116
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    October 1, 2023
    Report Date
    May 5, 2025
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER USING NUFACE MINI FOR 8-12 MONTHS I DEVELOPED SEVERE HYPOTHYROIDISM. MY PREGNANCY BLOOD TESTS FROM 2019 SHOW TOTALLY NORMAL T3 AND T4 LEVELS AND AFTER A YEAR OF FEELING SUPER CRAPPY IN 2023-2024 I TOOK ANOTHER BLOOD PANEL AND SHOWED A RAPID DECLINE IN MY THYROID HORMONE. I'VE READ THAT THERE'S BEEN OTHER PEOPLE WITH SIMILAR ISSUES AFTER USING THE NUFACE MINI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945439 NUFACE MINI+ STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Disability