MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE MINI; STIMULATOR, TRANCUTANEOUS ELECTRICAL

Model Number NUFACE MINI FACIAL TONING DEVICE

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Electric Shock (2554)

Event Date 02/04/2019

Event Type  Injury  

Event Description

I began using the nuface mini product in (b)(6).I have a blood pressure monitor.I noticed after using the device when i took my readings that the irregular heartbeat icon came on.I¿ve taken my bp for years and its never happened.It continued to happen while i was using the nuface mini and as soon as i quit using it regular readings quit happening.While i was using, i could feel the current and in my chest it felt like i could feel a current sensation which was odd.I didn¿t think much of it at first until the blood pressure monitor alerted me and then i became very aware of the strange feeling in my chest when i used the nuface mini.Purchased from (b)(6).

• Brand Name: NUFACE MINI
• Type of Device: STIMULATOR, TRANCUTANEOUS ELECTRICAL
• Manufacturer (Section D): CAROL COLE COMPANY
• MDR Report Key: 8470387
• MDR Text Key: 140546521
• Report Number: MW5085403
• Device Sequence Number: 0
• Product Code: NFO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: NUFACE MINI FACIAL TONING DEVICE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 60