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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUFACE TRINITY STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES

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NUFACE TRINITY STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Dizziness (2194); Sleep Dysfunction (2517)
Event Date 09/22/2020
Event Type  Injury  
Event Description
Started using nuface trinity a microcurrent facial. Developed pressure headaches, dizziness and insomnia.
 
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Brand NameNUFACE TRINITY
Type of DeviceSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
MDR Report Key10690136
MDR Text Key211898380
Report NumberMW5097269
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 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
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: 10/15/2020 Patient Sequence Number: 1
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