BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUFACE TRINITY

    MDR report key: 12450444 · Received September 9, 2021

    Report

    Report Number
    3006459199-2021-00001
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    June 1, 2017
    Report Date
    September 9, 2021
    Manufacturer
    CAROL COLE COMPANY
    Product Code
    NFO
    PMA / PMN Number
    K131251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, A USER OF THE NUFACE TRINITY DEVICE REPORTED EXPERIENCING SKIN RELATED DISORDERS ON THE FACE THAT THE USER ATTRIBUTED TO USE OF THE NUFACE DEVICE. THE USER REPORTED EXPERIENCING SEVERE SKIN DAMAGE TO THE FACE, INCLUDING, HYPERPIGMENTATION OF THE SKIN, ITCHINESS, HEAT, AND PAIN AFTER USING THE DEVICE TWICE ON HER FACE AND NECK COLLARBONE. THE USER CLAIMED SHE HAD VISITED MULTIPLE HOSPITALS AND DERMATOLOGISTS WHO INDICATED THERE WAS NO TREATMENT. THE USER STATED SHE RETURNED THE PRODUCT BACK TO THE DISTRIBUTION CENTER WHO SOLD HER THE DEVICE ON (B)(6) 2017. THE CLIENT DID NOT ALLEGE ANY POTENTIAL ADVERSE EFFECTS FROM THE DEVICE AT THE TIME OF RETURN. NO INVESTIGATION ON THE ALLEGED DEVICE CAN BE PERFORMED AS THE RETURN AND RETRIEVAL OF THE DEVICE IS PENDING. BASED ON THE INFORMATION PROVIDED, WE CANNOT CONFIRM THAT USE OF A NUFACE PRODUCT CAUSED OR CONTRIBUTED TO THE HEALTH EFFECTS DESCRIBED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345760 NUFACE TRINITY TRINITY NFO CAROL COLE COMPANY NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other