MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE MINI

Device Problems Labelling, Instructions for Use or Training Problem (1318); Off-Label Use (1494)

Patient Problems Arrhythmia (1721); Dizziness (2194)

Event Date 03/20/2021

Event Type  Injury  

Manufacturer Narrative

Also reported by user to fda under report number mw5100633.

Event Description

On (b)(6) 2021, nuface was made aware that a user of the nuface mini device reported an adverse reaction after a few weeks of using the device. According to the reporter, the user alleged she experienced arrythmia, dizziness and fainting. The user stated that she is a mitral valve patient, and it was determined the user was using the device in an off-label(or contrainicated) capacity. The user also alleged that the labeling was too small for her to read. The user indicated she stopped using the device and wears a heart monitor. The user stated she has several test scheduled with her cardiologist, which includes an echocardiogram. The alleged device has not been provided for investigation at the time of this report.

• Brand Name: NUFACE MINI
• Type of Device: NUFACE MINI
• 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: 12456776
• MDR Text Key: 272857466
• Report Number: 3006459199-2021-00002
• Device Sequence Number: 1
• Product Code: NFO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191672
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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 Received: 04/07/2021
• 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: Reuse

Patient Treatment Data

Date Received: 09/10/2021 Patient Sequence Number: 1