BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE "TRINITY" FACIAL TONING DEVICE

    MDR report key: 11613085 · Received April 2, 2021

    Report

    Report Number
    MW5100535
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 31, 2021
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A NUFACE "TRINITY" COSMETIC MICROCURRENT DEVICE IN (B)(6) 2021. AFTER USING IT FOR ONE WEEK ACCORDING TO THE DIRECTIONS, I DEVELOPED FACIAL PAIN THAT WAS NOT ALLEVIATED WITH OTC MEDICATIONS. UPON SEEING A PHYSICIAN TODAY, I WAS DIAGNOSED WITH TRIGEMINAL NEURALGIA, PRESCRIBED GABAPENTIN FOR THE ONGOING NERVE PAIN I AM EXPERIENCING AND REFERRED TO A NEUROLOGIST FOR FURTHER EVALUATION AND TREATMENT. I HAVE CONTACTED THE NUFACE COMPANY TWICE TO DISCUSS THIS MATTER AND HAVE RECEIVED ONLY ONE RESPONSE WHICH DID NOT ADDRESS MY CONCERNS. I STRONGLY SUGGEST THAT THIS DEVICE BE RE-EVALUATED TO DETERMINE ITS SAFETY TO CONSUMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508984 NUFACE "TRINITY" FACIAL TONING DEVICE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability