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CAROL COLE CO. NUFACE MINI Back to Search Results
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.
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Type of DeviceNUFACE MINI
Manufacturer (Section D)
MDR Report Key5694397
Report NumberMW5062603
Device Sequence Number1
Product Code NFO
Number of Events Reported1
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 Received05/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Patient Age50 YR
Patient Weight61
Patient Outcome(s) Other;