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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROL COLE COMPANY DBA NUFACE NUFACE TRINITY DEVICE AND ELE ATTACHMENT STIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES

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CAROL COLE COMPANY DBA NUFACE NUFACE TRINITY DEVICE AND ELE ATTACHMENT STIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Inflammation (1932)
Event Date 12/27/2019
Event Type  Injury  
Manufacturer Narrative
We are continuing our effort to further investigate and gain more information regarding the customer's medical history and doctor evaluations.
 
Event Description
End user experienced fluid build up inside both eyes, got a subconjunctival hemorrhage in left eye, swelling under both eyes, inflamed nerves throughout face and inside of mouth, headaches, feeling sensitivity to gums and teeth after using the device as directed for approximately 1 month. The end user discontinued use of the device and was seen by her eye doctor. After 7 weeks the end user stated she is still so inflamed and eyes have not healed.
 
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Brand NameNUFACE TRINITY DEVICE AND ELE ATTACHMENT
Type of DeviceSTIMULATOR, TRANSCUTANEOUS ELECTRICAL AESTHETIC PURPOSES
Manufacturer (Section D)
CAROL COLE COMPANY DBA NUFACE
1324 sycamore avenue
suite a
vista CA 92081
Manufacturer (Section G)
CAROL COLE COMPANY DBA NUFACE
1325 sycamore avenue
suite a
vista CA 92081
Manufacturer Contact
alexis perry
1325 sycamore avenue
suite a
vista, CA 92081
7605091259
MDR Report Key10679917
MDR Text Key211487006
Report Number3006459199-2020-00004
Device Sequence Number1
Product Code NFO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181008
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 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
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 Received02/25/2020
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

Patient Treatment Data
Date Received: 10/14/2020 Patient Sequence Number: 1
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