MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE TRINITY DEVICE AND ELE ATTACHMENT; STIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES

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

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Inflammation (1932); Increased Sensitivity (2065); Swelling (2091)

Event Date 12/27/2019

Event Type  Injury  

Event Description

I used the nuface trinity device for about 1 month as directed which they said is fda cleared.I got seriously horrific side effects where there is fluid build up inside both eyes, got a subconjunctival hemorrhage in left eye, swelling under both eyes, inflamed nerves throughout face and inside of mouth, headaches, feeling sensitivity to gums and teeth.I have been to my eye dr multiple times and he said he would never recommend this device to anyone as there are too many nerves in face and eyes.It has been 7 weeks since stopped using this device and i am still so inflamed and eyes have not healed.This has been a very scary experience.This device is not safe and is extremely dangerous.And it is for a temporary fix which is not worth the risks involved.This product should be taken off the market.

• Brand Name: NUFACE TRINITY DEVICE AND ELE ATTACHMENT
• Type of Device: STIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES
• Manufacturer (Section D): CAROL COLE COMPANY
• MDR Report Key: 9744913
• MDR Text Key: 180870142
• Report Number: MW5093223
• Device Sequence Number: 1
• Product Code: NFO
• Combination Product (y/n): Y
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 59