BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NU SKIN FACIAL SPA

    MDR report key: 22212941 · Received June 16, 2025

    Report

    Report Number
    3001236514-2025-00001
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    December 1, 2024
    Report Date
    June 16, 2025
    Manufacturer
    NSE PRODUCTS, INC.
    Product Code
    NFO
    UDI-DI
    00860196000303
    PMA / PMN Number
    K122711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ADVERSE EVENT REPORT IS SUBMITTED SOLELY IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING (MDR) REQUIREMENTS UNDER 21 CFR PART 803 AND DOES NOT CONSTITUTE AN ADMISSION OF LIABILITY, FAULT, OR RESPONSIBILITY BY NSE PRODUCTS, INC, NU SKIN ENTERPRISES, UNITED STATES INC., OR ITS PARENT COMPANY NU SKIN INTERNATIONAL, INC. (COLLECTIVELY "NU SKIN") FOR THE REPORTED INCIDENT OR ANY ALLEGED INJURIES. NU SKIN EXPRESSLY DISCLAIMS ANY AND ALL LIABILITY RELATED TO THE REPORTED ADVERSE EVENT. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT OR ANY ALLEGED INJURY; AN ACKNOWLEDGMENT OF ANY DEFECT, MALFUNCTION, OR INADEQUACY IN THE DEVICE; OR AN ADMISSION OF ANY BREACH OF WARRANTY, NEGLIGENCE, OR OTHER LEGAL DUTY. NU SKIN EXPRESSLY RESERVES ALL LEGAL RIGHTS AND DEFENSES AVAILABLE UNDER APPLICABLE LAW. THIS SUBMISSION IS MADE WITHOUT PREJUDICE TO THE COMPANY'S POSITION REGARDING CAUSATION, LIABILITY, OR ANY OTHER LEGAL OR FACTUAL ISSUES RELATED TO THE REPORTED INCIDENT. ALL PRODUCTS FROM LOT: 2D3 WERE ASSESSED BY QUALITY AND PASSED SPECIFICATION REQUIREMENTS PRIOR TO BEING AVAILABLE FOR SALE. THE FACIAL SPA DEVICE WAS RETURNED AND DESTROYED UPON ITS RECEIPT.

    Description of Event or Problem · 0

    ON 19-MAY-2025, A SPONTANEOUS REPORT WAS RECEIVED VIA TELEPHONE REGARDING A FEMALE (AGE NOT PROVIDED) WHO USED NU SKIN FACIAL SPA AND NU SKIN CONDUCTIVE GEL (REFER TO ASSOCIATED REPORT). ON AN UNSPECIFIED DATE ON (B)(6) 2024, THE CONSUMER STARTED USING THE PRODUCTS. APPROXIMATELY 3 WEEKS AFTER USING THE PRODUCTS, SHE STARTED TO NOTICE ONE OF HER EYELIDS WAS DROOPING OR SAGGING. SHE DID NOT NOTICE ANY BENEFIT FROM THE PRODUCTS. HER HUSBAND COULDN'T TELL ANY DIFFERENCE BUT WHEN SHE LOOKED AT OLD PICTURES SHE COULD. SHE THOUGHT HER ENTIRE FOREHEAD WAS SAGGING DOWNWARD. OVER TIME SHE NOTICED HER EYELIDS AND EYEBROWS WERE SAGGING TO WHERE IT AFFECTED HER VISION AND SHE HAD A DAILY HEADACHE. SHE DISCONTINUED THE PRODUCT ON (B)(6) 2025. ON AN UNSPECIFIED DATE SHE VISITED HER PRIMARY CARE PROVIDER WHO RECOMMENDED SHE SEE AN EYE DOCTOR. WHEN SHE VISITED AN EYE DOCTOR A VISION TEST WAS DONE WHICH SHE REPORTED 47% OF HER VISION WAS AFFECTED BY THE SAGGING SKIN. SHE THEN MADE AN APPOINTMENT WITH AN EYE SURGEON WHO MEASURED THE DISTANCE FROM HER PUPILS TO HER EYELIDS. SHE ANTICIPATED HAVING SURGERY ON (B)(6) 2025. AT THE TIME OF THE REPORT THE SYMPTOMS WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009500 NU SKIN FACIAL SPA FACIAL SPA NFO NSE PRODUCTS, INC. 00860196000303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention BEEF TALLOW APPLIED TOPICALLY.