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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE MINI

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CAROL COLE COMPANY NUFACE MINI Back to Search Results
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.
 
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Brand NameNUFACE MINI
Type of DeviceNUFACE 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 Key12456776
MDR Text Key272857466
Report Number3006459199-2021-00002
Device Sequence Number1
Product Code NFO
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K191672
Number of Events Reported1
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 Received09/10/2021
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 Received04/07/2021
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
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