MAUDE Adverse Event Report: CAROL COLE COMPANY DBA NUFACE NUFACE TRINITY PLUS FACIAL AND NECK TONING DEVICE; STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES

Health Effect - Clinical Codes	Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Myalgia (2238); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Personal experience and safety concerns.As a consumer, i experienced severe adverse reactions after using this device according to all provided instructions.Within hours of my first use, i developed intense facial nerve pain, persistent skin irritation, and inflammatory breakouts that required medical attention.My experience aligns with many other customers reporting identical severe reactions: permanent acne scarring, nerve damage requiring neurologist consultation, rosacea activation, and systemic effects including sleep disruption and muscle pain.This product is causing medical-grade adverse effects yet lacks proper fda medical device registration.Therefore, i recently explored the nuface trinity+ facial and neck toning device (fda clearance number: (b)(4), product device after reviewing its 510(k) submissions, i noticed a critical discrepancy between its fda-cleared indications and promotional claims.The 510(k) document specifies the device's intended uses as "facial and neck stimulation" and "microcurrent therapy".However, both the product packaging and official website advertise unapproved benefits, including: - "lift," "contour," and "tone jawline" on the packaging; - "sculpt," "lift," and "contour" on the website (https://www.Mynuface.Com).This constitutes off-label promotion in violation of fda regulations (21 cfr § 807.97), which prohibits advertising devices beyond their cleared indications.Additionally, nuface markets the product as "clinically proven," yet the 510(k) filing explicitly states no clinical studies were conducted to support these claims, raising concerns about false advertising.Additionally, this also violates fd&c act § 510(k), which requires premarket notification for class ii devices before claiming medical uses.Request for action.- enforce 510(k) registrations: -remove "nuface" from the market until 510(k) clearance and establishment registration are confirmed.- issue warning letters: cite violations of fd&c act, 21 cfr labeling rules, and ftc act.- public warning: alert consumers via "fda¿s" medwatch.

• Brand Name: NUFACE TRINITY PLUS FACIAL AND NECK TONING DEVICE
• Common Device Name: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): CAROL COLE COMPANY DBA NUFACE
• MDR Report Key: 23170126
• Report Number: MW5176749
• Device Sequence Number: 9245606
• Product Code: NFO
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/25/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability; Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: American Indian Or Alaskan Native