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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nerve Damage (1979); Neuralgia (4413)

Event Date 03/15/2021

Event Type  Injury  

Event Description

I purchased a nuface "trinity" cosmetic microcurrent device in (b)(6) 2021.After using it for one week according to the directions, i developed facial pain that was not alleviated with otc medications.Upon seeing a physician today, i was diagnosed with trigeminal neuralgia, prescribed gabapentin for the ongoing nerve pain i am experiencing and referred to a neurologist for further evaluation and treatment.I have contacted the nuface company twice to discuss this matter and have received only one response which did not address my concerns.I strongly suggest that this device be re-evaluated to determine its safety to consumers.

• Brand Name: NUFACE "TRINITY" FACIAL TONING DEVICE
• Type of Device: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): CAROL COLE COMPANY
• MDR Report Key: 11613085
• MDR Text Key: 244180181
• Report Number: MW5100535
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Weight: 46