BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE TRINITY DEVICE AND ELE ATTACHMENT

    MDR report key: 10679917 · Received October 14, 2020

    Report

    Report Number
    3006459199-2020-00004
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    December 27, 2019
    Report Date
    October 2, 2020
    Manufacturer
    CAROL COLE COMPANY DBA NUFACE
    Product Code
    NFO
    PMA / PMN Number
    K181008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CONTINUING OUR EFFORT TO FURTHER INVESTIGATE AND GAIN MORE INFORMATION REGARDING THE CUSTOMER'S MEDICAL HISTORY AND DOCTOR EVALUATIONS.

    Description of Event or Problem · 1

    END USER EXPERIENCED 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 AFTER USING THE DEVICE AS DIRECTED FOR APPROXIMATELY 1 MONTH. THE END USER DISCONTINUED USE OF THE DEVICE AND WAS SEEN BY HER EYE DOCTOR . AFTER 7 WEEKS THE END USER STATED SHE IS STILL SO INFLAMED AND EYES HAVE NOT HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142546 NUFACE TRINITY DEVICE AND ELE ATTACHMENT STIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES NFO CAROL COLE COMPANY DBA NUFACE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention