MAUDE Adverse Event Report: CAROL COLE CO. NUFACE MINI

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Dry Eye(s) (1814); Hot Flashes/Flushes (2153); Dizziness (2194)

Event Date 05/25/2016

Event Type  Injury  

Event Description

I used an fda cleared microcurrent device called nuface for the first time and followed the product instructions.During the treatment, i saw some flashes in my eyes, but i had no other unusual effects.However, later in the day, my eyes started to feel sore, and became extremely dry.Additionally, i started having an irregular heart rhythm, chest pain, dizziness, and lightheadedness.I referred to the product instruction booklet, and the booklet does state that the optic nerve can get stimulated during treatment, and that flashes may appear, but should stop once the device is turned off.Also, the book cautioned users that the electrical current may cause rhythmic disturbances to the heart, which could be lethal.I used this device as directed, and did not put it anywhere near my chest/heart area, but may be the electrical current could travel to that area from use on the jawline? two days later, i am still feeling the adverse effects.I looked up reviews for the product to see if anyone else reported these type of reactions, and many people have had similar reactions.Thyroid issues were also reported, but so far that does not apply to me.I am horrified i may have lingering/long-term effects/damage due to this device.

• Brand Name: NUFACE MINI
• Type of Device: NUFACE MINI
• Manufacturer (Section D): CAROL COLE CO.
• MDR Report Key: 5694397
• MDR Text Key: 46517642
• Report Number: MW5062603
• Device Sequence Number: 1
• Product Code: NFO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 61