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

Lot Number L-0309.V2

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Chemical Exposure (2570); Skin Inflammation/ Irritation (4545)

Event Date 08/09/2022

Event Type  Injury  

Event Description

I purchased an fda approved nuface microcurrent mini device and gel.I used it exactly as in instruction.When i just started using it my face was clean from acne or any type of inflammation.In fact never had any allergies or skin issues.After 3 days of using it i noticed 2-3 acne-like spots on my forehead.I didn't think that it could be caused by the device or gel so i kept using the product.After i noticed more spots a couple days later, i stopped using nuface.Even though i stopped there were even more spots gradually showing up on my face on following days.They were big and very painful.At one point my face and neck was completely covered by something that looked like acne.I eventually had to go to the emergency room, got two injections and 3 strong antibiotics.I contacted nuface with a complaint.The company has only accepted the return of the product, but has not offered any type of compensation even though i sent them a report from the doctor i saw at the emergency room.They just kept telling me that my case has been reviewed.Their last email stated that if they decide to do something about my case they will let me know, but if not they won't send me any email.I have all the emails between me and them saved as proof.It took me almost two months to heal.I was not able to work for two weeks cause my face looked so bad.I am very disappointed that the company did not take any type of responsibility for what happened.My cosmetologist said to him it looked like a chemical burn most likely caused by gel ingredients.Even though i am sure some people don't have any issue with the product, my experience was horrible and i don't think the product is safe for everyone.Fda safety report id# (b)(4).

• Brand Name: NUFACE MINI FACIAL TONING DEVICE
• Type of Device: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): CAROL COLE COMPANY
• MDR Report Key: 15799694
• MDR Text Key: 303749693
• Report Number: MW5113256
• 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: 11/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: L-0309.V2
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White