MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE TRINITY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Rash (2033)

Event Date 06/01/2017

Event Type  Injury  

Event Description

On (b)(6) 2021, a user of the nuface trinity device reported experiencing skin related disorders on the face that the user attributed to use of the nuface device.The user reported experiencing severe skin damage to the face, including, hyperpigmentation of the skin, itchiness, heat, and pain after using the device twice on her face and neck collarbone.The user claimed she had visited multiple hospitals and dermatologists who indicated there was no treatment.The user stated she returned the product back to the distribution center who sold her the device on (b)(6) 2017.The client did not allege any potential adverse effects from the device at the time of return.No investigation on the alleged device can be performed as the return and retrieval of the device is pending.Based on the information provided, we cannot confirm that use of a nuface product caused or contributed to the health effects described by the user.

• Brand Name: NUFACE TRINITY
• Type of Device: TRINITY
• Manufacturer (Section D): CAROL COLE COMPANY; 1325 sycamore ave; ste a; vista CA 92081
• Manufacturer Contact: robert castro ; 1325 sycamore ave; ste a; vista, CA 92081
• MDR Report Key: 12450444
• MDR Text Key: 270799631
• Report Number: 3006459199-2021-00001
• Device Sequence Number: 1
• Product Code: NFO
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: K131251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 05/16/2021
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other