BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE TRINITY DEVICE AND ELE ATTACHMENT

    MDR report key: 9744913 · Received February 21, 2020

    Report

    Report Number
    MW5093223
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    December 27, 2019
    Report Date
    February 19, 2020
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THE NUFACE TRINITY DEVICE FOR ABOUT 1 MONTH AS DIRECTED WHICH THEY SAID IS FDA CLEARED. I GOT SERIOUSLY HORRIFIC SIDE EFFECTS WHERE THERE IS FLUID BUILD UP INSIDE BOTH EYES, GOT A SUBCONJUNCTIVAL HEMORRHAGE IN LEFT EYE, SWELLING UNDER BOTH EYES, INFLAMED NERVES THROUGHOUT FACE AND INSIDE OF MOUTH, HEADACHES, FEELING SENSITIVITY TO GUMS AND TEETH. I HAVE BEEN TO MY EYE DR MULTIPLE TIMES AND HE SAID HE WOULD NEVER RECOMMEND THIS DEVICE TO ANYONE AS THERE ARE TOO MANY NERVES IN FACE AND EYES. IT HAS BEEN 7 WEEKS SINCE STOPPED USING THIS DEVICE AND I AM STILL SO INFLAMED AND EYES HAVE NOT HEALED. THIS HAS BEEN A VERY SCARY EXPERIENCE. THIS DEVICE IS NOT SAFE AND IS EXTREMELY DANGEROUS. AND IT IS FOR A TEMPORARY FIX WHICH IS NOT WORTH THE RISKS INVOLVED. THIS PRODUCT SHOULD BE TAKEN OFF THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205614 NUFACE TRINITY DEVICE AND ELE ATTACHMENT STIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES NFO CAROL COLE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR