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

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.

• Brand Name: NUFACE TRINITY DEVICE AND ELE ATTACHMENT
• Type of Device: STIMULATOR, 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 Key: 10679917
• MDR Text Key: 211487006
• Report Number: 3006459199-2020-00004
• Device Sequence Number: 1
• Product Code: NFO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181008
• Number of Events Reported: 1
• 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 Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention