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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES; FACIAL LIFE AND TONING
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CAROL COLE COMPANY NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES; FACIAL LIFE AND TONING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Peeling (1999)
Event Date 04/21/2015
Event Type  Injury  
Event Description
This is (b)(6), a customer who purchased nuface microcurrent facial lifting and toning devices several weeks ago.After using this device three times following the user's instruction, i have had really severe side effects: my face skin became dry and red, then started to peel off and left dark red spot on my face.I contacted customer service from nuface and got the resolution on refund the purchase.However, they are not responsible for the medication service and salary loss for me at this moment.As the nuface device was authorized by fda, i was wondering whether you could help to reevaluate this device.I don't want to see other people suffering side effects that i have been through.Please let me know if you have any questions or need any info.I can send you the proof of my purchase and the side effect pictures (i have pictures before and after using the device).Thank you very much for your time and help.Dates of use: (b)(6) 2015; diagnosis or reason for use: wanted to decrease the wrinkle on the face.
 
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Brand Name
NUFACE MICROCURRENT FACIAL LIFTING AND TONING DEVICES
Type of Device
FACIAL LIFE AND TONING
Manufacturer (Section D)
CAROL COLE COMPANY
MDR Report Key4728007
MDR Text Key5663409
Report NumberMW5042237
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 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age31 YR
Patient Weight52
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