BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE MINI FACIAL TONING DEVICE

    MDR report key: 5836223 · Received July 27, 2016

    Report

    Report Number
    MW5063755
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    June 22, 2016
    Report Date
    July 27, 2016
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING NUFACE MINI FACIAL TONING DEVICE FOR APPROX 4 WEEKS MY TOOTH/CROWN BECAME LOOSE AND FELL OUT OF MY MOUTH. I HAVE BEEN IN CONTACT WITH NUFACE AND ADVISED THEM OF MY EXPERIENCE. I CAN'T IMAGINE I AM THE ONLY WOMAN WITH CROWNS IN HER MOUTH AND WOULD LIKE TO KNOW IF THIS MICRO CURRENT CAN VIBRATE CRACKS IN THE MATERIAL THAT SEATS CROWNS. I AM RELUCTANT TO CONTINUE USE OF THIS DEVICE UNTIL I KNOW THIS MICRO CURRENT IS SAFE FOR USE BY PEOPLE WITH CROWNS ON THEIR TEETH. ROUTE: APPLIED TO A SURFACE, USUALLY THE SKIN. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: COSMETIC/FACIAL TONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479972 NUFACE MINI FACIAL TONING DEVICE SKIN TONER NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| S