BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE

    MDR report key: 2211411 · Received August 8, 2011

    Report

    Report Number
    3006459199-2011-00001
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    March 16, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE AWAITING A CONFIRMED DIAGNOSIS FROM THE DERMATOLOGIST WHO SAW THE SUBJECT.

    Description of Event or Problem · 1

    PT EMAILED CORPORATE ON (B)(6) 2011 AND CLAIMED "NUFACE BROKE ALL OF THE CAPILLARIES ON MY FACE. "HE CLAIMED HE FOLLOWED THE INSTRUCTIONS CAREFULLY, USED IT WITH OTHER ANTI-AGING SERUMS, AND HAD NEVER EXPERIENCED THE ISSUE BEFORE. HE HAD ALREADY RETURNED FOR REFUND TO THE RETAILER PURCHASED ON (B)(6) 2011. DEVICE WAS TESTED WHEN RETURNED FROM RETAILER AND NO DEFECTS WERE FOUND. CORPORATE INSTRUCTED PT TO CONSULT A DERMATOLOGIST TO DETERMINE CAUSE OF BROKEN CAPILLARIES. A LETTER WAS SENT FROM THE DERMATOLOGIST ON (B)(6) 2011 WITH THE FOLLOWING NOTES: "A THOROUGH EXAM YIELDED THE FOLLOWING: RED AND BLUE FINE TELANGIECTASIAS SCATTERED ON HIS CHEST AND FACE. OUR IMPRESSION: TELANGIECTASIAS POSSIBLY CAUSED BY MICROCURRENT DEVICE. PT HAS NO MEDICAL PROBLEM THAT WOULD INDICATE THAT THE TELANGIECTASIAS ARE PATHOLOGIC IN NATURE. RECOMMENDATIONS AND MGMT: (B)(6) IS A GOOD CANDIDATE FOR VBEAM AND ELECTRODESICCATION TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUFACE NUFACE NFO CAROL COLE COMPANY NUFACE CLASSIC INV000060670

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR