BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE

    MDR report key: 11633638 · Received April 7, 2021

    Report

    Report Number
    MW5100633
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 20, 2021
    Report Date
    April 5, 2021
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ARRHYTHMIA AND PALPITATIONS; I WAS USING THE NUFACE MINI FACIAL MICROCURRENT TONING DEVICE. AFTER USING THIS DEVICE FOR A FEW WEEKS; I HAD SERIOUS ARRHYTHMIA OCCUR DAILY AFTER USE. THE MANUAL THAT CAME WITH THIS PRODUCT HAD EXTREMELY SMALL PRINTED PRECAUTIONARY STATEMENTS. THE LETTERING WAS PRINTED WITH EXTREMELY LIGHT COLORED INK; HOWEVER I WAS ABLE TO NOTE THAT THE STATEMENTS WERE CLEAR THAT ARRHYTHMIA FROM THIS PRODUCT COULD BE LETHAL I AM A MITRAL VALVE PATIENT AND WAS SHOCKED WHEN I REALIZED THAT A BEAUTY TOOL COULD HAVE KILL ME. THERE IS NOT ENOUGH INFORMATION CLEARLY WRITTEN TO PROTECT CUSTOMERS ON THIS PRODUCT, AND ESPECIALLY THERE IS NOT INFORMATION PRINTED ABOUT PEOPLE WHO SHOULD NOT USE THIS DANGEROUS PRODUCT. I CALLED MY CARDIOLOGIST AND AT THE TIME I HAD NOT PUT "TWO AND TWO TOGETHER " AND I WAS AT A LOSS AS TO WHAT WAS CAUSING THESE FRIGHTENING ARRHYTHMIA'S AND DIZZINESS, FAINTING FEELING, BUT AFTER SEVERAL WEEKS ON A HEART MONITOR, I REALIZED IT COULD BE THE NUFACE DEVICE. I STOPPED USING IT IMMEDIATELY, HOWEVER I HAVE HAD A HEART MONITOR ON FOR 14 DAYS AND HAVE SEVERAL TESTS TO DO WITH MY CARDIOLOGIST AND I AM PRAYING THIS MACHINE HAS NOT CAUSED MY HEART SERIOUS DAMAGE FOR THE TWO MONTHS I USED IT. I WILL BE HAVING AN ECHO CARDIOGRAM ON (B)(6) 2021 AND I WORE THE HEART MONITOR FOR 14 DAYS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526267 NUFACE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO CAROL COLE COMPANY NOT AVAILABLE ON BOX OR PRODUCT DHR433

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other