BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE MINI

    MDR report key: 12456776 · Received September 10, 2021

    Report

    Report Number
    3006459199-2021-00002
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    March 20, 2021
    Report Date
    September 10, 2021
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    PMA / PMN Number
    K191672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ALSO REPORTED BY USER TO FDA UNDER REPORT NUMBER MW5100633.

    Description of Event or Problem · 1

    ON (B)(6) 2021, NUFACE WAS MADE AWARE THAT A USER OF THE NUFACE MINI DEVICE REPORTED AN ADVERSE REACTION AFTER A FEW WEEKS OF USING THE DEVICE. ACCORDING TO THE REPORTER, THE USER ALLEGED SHE EXPERIENCED ARRYTHMIA, DIZZINESS AND FAINTING. THE USER STATED THAT SHE IS A MITRAL VALVE PATIENT, AND IT WAS DETERMINED THE USER WAS USING THE DEVICE IN AN OFF-LABEL(OR CONTRAINICATED) CAPACITY. THE USER ALSO ALLEGED THAT THE LABELING WAS TOO SMALL FOR HER TO READ. THE USER INDICATED SHE STOPPED USING THE DEVICE AND WEARS A HEART MONITOR. THE USER STATED SHE HAS SEVERAL TEST SCHEDULED WITH HER CARDIOLOGIST, WHICH INCLUDES AN ECHOCARDIOGRAM. THE ALLEGED DEVICE HAS NOT BEEN PROVIDED FOR INVESTIGATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353487 NUFACE MINI NUFACE MINI NFO CAROL COLE COMPANY NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other