• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUFACE NUFACE MINI

  • 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 NUFACE MINI Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Swelling (2091)
Event Date 07/28/2020
Event Type  Injury  
Event Description
End user experienced an enlarged thyroid, ear pain and problems swallowing after one 5 minute treatment on the face using the nuface mini device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNUFACE MINI
Type of DeviceNUFACE MINI
Manufacturer (Section D)
NUFACE
1325 sycamore avenue
suite a
vista 92081
Manufacturer (Section G)
NUFACE
1325 sycamore avenue
suite a
vista 92081
Manufacturer Contact
alexis perry
1325 sycamore avenue
suite a
vista 92081
7605091259
MDR Report Key10577136
MDR Text Key208293990
Report Number3006459199-2020-00001
Device Sequence Number1
Product Code NFO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3006459199

Patient Treatment Data
Date Received: 09/23/2020 Patient Sequence Number: 1
-
-