BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE TRINITY+

    MDR report key: 19097090 · Received April 11, 2024

    Report

    Report Number
    MW5153785
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 9, 2024
    Manufacturer
    NUFACE BY CAROL COLE / CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM A 35-YEAR-OLD FEMALE WITH NO EXISTING HEALTH CONDITIONS. I STARTED USING NUFACE FIRST WEEK OF (B)(6). AFTER TWO WEEKS, I STARTED NOTICING SOME INTERMITTENT CHEST DISCOMFORT AND POUNDING OF MY HEART. IT PROGRESSED TO THE POINT THAT IN THE PAST FEW DAYS, IT HAS BEEN CONSTANT AND I'VE BEEN SYMPTOMATIC (NAUSEA, SHORTNESS OF BREATH). I AM NOW WEARING A 7-DAY RHYTHM MONITOR TO ASSESS THE ACTUAL RHYTHM, BUT IT IS CONFIRMED IRREGULAR ON PHYSICAL EXAM. I BELIEVE THE NUFACE DEVICE CONTRIBUTED TO THIS. ALL MY BLOODWORK (CBC, CMP, MAGNESIUM) HAS BEEN FINE AS OF (B)(6) 2024. I AM RETURNING THE DEVICE TO GET A REFUND AND ALSO CONTACTING THE FDA AND THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832824 NUFACE TRINITY+ STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES NFO NUFACE BY CAROL COLE / CAROL COLE COMPANY DHR2964

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other| R| S BIRTH CONTROL PILL.