MAUDE Adverse Event Report: CAROL COLE COMPANY DBA NUFACE NUFACE; NUFACE TRINITY

Model Number 40150

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

Patient Problems Arrhythmia (1721); Laceration(s) (1946); Loss of consciousness (2418)

Event Date 07/29/2022

Event Type  Injury  

Event Description

It was reported on (b)(6) 2022, a user of the nuface trinity device was admitted to the hospital after use of the trinity device.This case was provided to our internal medical reviewer and her report is summarized below.No product has been returned for investigation.This case involves an acute condition which reportedly occurred after chronic use (approximately 1 year) of the reported product.The consumer's complete medical history is unknown, although her report indicates that she was taking blood pressure medication at the time of the reported incident (medication type and dose not otherwise specified).Furthermore, based on the information provided to date, the consumer's report references product literature, which notes that the pre-existing cardiovascular conditions are a potential contraindication for product use and that consultation with a health care provider prior to product use is recommended.The consumer acknowledged contraindications included in product literature and with even the limited knowledge of her medical history, it would have been prudent for her to have sought medical direction before beginning product use.The reported incident involves a serious event, specifically arrythmia (assumed intervention was received to correct the condition although not specified) and hospitalization.Based on the chronic/daily use of the reported product for approximately 1 year without incident, no indication from the consumer that the product malfunctioned at the time of onset or at any point during the year prior, and the variety of underlying health considerations that are more plausible explanations for the acute onset of the reported event, it is most likely that the reported product use is not associated with the reported incident.However, in the absence of a complete medical history and/or additional objective data (e.G.Laboratory results, head ct report, etc), the most likely etiology(s) associated with the reported event cannot be ascertained at this time.

Manufacturer Narrative

This event was also reported by the user via a voluntary medwatch under report number mw5111432.

• Brand Name: NUFACE
• Type of Device: NUFACE TRINITY
• Manufacturer (Section D): CAROL COLE COMPANY DBA NUFACE; 1325 sycamore ave; ste a; vista CA 92081
• Manufacturer Contact: robert castro ; 1325 sycamore ave; ste a; vista, CA 92081 ; 7607344545
• MDR Report Key: 15620783
• MDR Text Key: 301905575
• Report Number: 3006459199-2022-00002
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 40150
• Device Lot Number: DHR1264
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED BLOOD PRESSURE MEDICATION.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female