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U.S. Department of Health and Human Services

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

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CAROL COLE COMPANY NUFACE "TRINITY" FACIAL TONING DEVICE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES Back to Search Results
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.
 
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Brand NameNUFACE "TRINITY" FACIAL TONING DEVICE
Type of DeviceSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
Manufacturer (Section D)
CAROL COLE COMPANY
MDR Report Key11613085
MDR Text Key244180181
Report NumberMW5100535
Device Sequence Number1
Product Code NFO
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Received04/02/2021
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/02/2021 Patient Sequence Number: 1
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