Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUFACE TRINITY; STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NUFACE TRINITY
Type of Device
STIMULATOR, 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 No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age41 YR
-
-