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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Inflammation (1932); Itching Sensation (1943); Nausea (1970); Skin Discoloration (2074); Sore Throat (2396); Swollen Lymph Nodes/Glands (4432); Eye Pain (4467)

Event Date 03/17/2022

Event Type  Injury  

Event Description

Used device on highest level consistent with instructions and instructional videos by nuface and its endorsers.Avoided thyroid as instructed.Sudden onset of itching along jaw line and neck, centralizing in skin above thyroid.Thyroid skin became striated and incredibly itchy.Accompanied by racing heart, heart palpitations, inflammation of neck lymph nodes, general exhaustion and nausea, congestion and inflammation, left eye pain.Eventually, itchiness subsided and thyroid became inflamed and felt as if swallowing over something.Met with pcp, who ordered round of bloodwork and thyroid ultrasound.Bloodwork indicated normal tsh and t3 numbers.Thyroid ultrasound indicated hypervascular thyroid gland suggesting sudden onset of thyroiditis.The only new activity in my life was nuface.No new body care, dermatological treatments, external stressors, or otherwise.Other bloodwork and blood count normal.Device returned to nuface (order no.(b)(4)) and reported adverse event (complaint no.(b)(4)).I do not believe this device should be approved for use on neck at all given these risks.

• Brand Name: NUFACE TRINITY FACIAL TONING DEVICE
• Type of Device: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): CAROL COLE COMPANY; 1325 sycamore ave ste a; vista CA 92081 7889
• MDR Report Key: 14105061
• MDR Text Key: 289299172
• Report Number: MW5108954
• Device Sequence Number: 1
• Product Code: NFO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: FISH OIL; GLUCOSAMINE. ALL TAKEN FOR OVER 1.5 YEARS BEFORE USE OF NUFACE DEVICE. NOT CHANGED AT TIME OF USAGE.; LO-OVAL BIRTH CONTROL; MULTIVITAMIN; PROBIOTIC
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White