NUFACE MINI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for NUFACE MINI manufactured by Carol Cole Co..

Event Text Entries

[46517642] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062603
• MDR Report Key: 5694397
• Date Received: 2016-05-27
• Date of Report: 2016-05-27
• Date of Event: 2016-05-25
• Date Added to Maude: 2016-06-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: NUFACE MINI
• Generic Name: NUFACE MINI
• Product Code: NFO
• Date Received: 2016-05-27
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CAROL COLE CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-05-27