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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

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Type of DeviceNUFACE MINI
Manufacturer (Section D)
1325 sycamore avenue
suite a
vista 92081
Manufacturer (Section G)
1325 sycamore avenue
suite a
vista 92081
Manufacturer Contact
alexis perry
1325 sycamore avenue
suite a
vista 92081
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
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