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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE MINI STIMULATOR, TRANCUTANEOUS ELECTRICAL
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CAROL COLE COMPANY NUFACE MINI STIMULATOR, TRANCUTANEOUS ELECTRICAL Back to Search Results
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).
 
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Brand NameNUFACE MINI
Type of DeviceSTIMULATOR, TRANCUTANEOUS ELECTRICAL
Manufacturer (Section D)
CAROL COLE COMPANY
MDR Report Key8470387
MDR Text Key140546521
Report NumberMW5085403
Device Sequence Number0
Product Code NFO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNUFACE MINI FACIAL TONING DEVICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/29/2019 Patient Sequence Number: 1
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