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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES

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CAROL COLE COMPANY NUFACE STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES Back to Search Results
Model Number NOT AVAILABLE ON BOX OR PRODUCT
Device Problems Device Markings/Labelling Problem (2911); Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problems Arrhythmia (1721); Dizziness (2194); Presyncope (4410)
Event Date 03/20/2021
Event Type  Injury  
Event Description
Arrhythmia and palpitations; i was using the nuface mini facial microcurrent toning device. After using this device for a few weeks; i had serious arrhythmia occur daily after use. The manual that came with this product had extremely small printed precautionary statements. The lettering was printed with extremely light colored ink; however i was able to note that the statements were clear that arrhythmia from this product could be lethal i am a mitral valve patient and was shocked when i realized that a beauty tool could have kill me. There is not enough information clearly written to protect customers on this product, and especially there is not information printed about people who should not use this dangerous product. I called my cardiologist and at the time i had not put "two and two together " and i was at a loss as to what was causing these frightening arrhythmia's and dizziness, fainting feeling, but after several weeks on a heart monitor, i realized it could be the nuface device. I stopped using it immediately, however i have had a heart monitor on for 14 days and have several tests to do with my cardiologist and i am praying this machine has not caused my heart serious damage for the two months i used it. I will be having an echo cardiogram on (b)(6) 2021 and i wore the heart monitor for 14 days. Fda safety report id # (b)(4).
 
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Brand NameNUFACE
Type of DeviceSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
Manufacturer (Section D)
CAROL COLE COMPANY
MDR Report Key11633638
MDR Text Key244639164
Report NumberMW5100633
Device Sequence Number1
Product Code NFO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNOT AVAILABLE ON BOX OR PRODUCT
Device Catalogue NumberNOT AVAILABLE ON PRODUCT OR BO
Device Lot NumberDHR433
Was Device Available for Evaluation? Yes
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: 04/07/2021 Patient Sequence Number: 1
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