MAUDE Adverse Event Report: NSE PRODUCTS, INC. NU SKIN FACIAL SPA

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Skin Disorders (4543)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: NU SKIN FACIAL SPA
• Common Device Name: FACIAL SPA
• Manufacturer (Section D): NSE PRODUCTS, INC.; 75 w center street; provo UT 84601
• Manufacturer (Section G): NSE PRODUCTS, INC.; 75 w center street; provo UT 84602
• Manufacturer Contact: chris leiter ; 75 w center street; provo, UT 84601 ; 8013452247
• MDR Report Key: 22212941
• Report Number: 3001236514-2025-00001
• Device Sequence Number: 18182278
• Product Code: NFO
• UDI-Device Identifier: 00860196000303
• UDI-Public: 00860196000303
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BEEF TALLOW APPLIED TOPICALLY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female