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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAROL COLE COMPANY NUFACE TRINITY

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CAROL COLE COMPANY NUFACE TRINITY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Rash (2033)
Event Date 06/01/2017
Event Type  Injury  
Event Description
On (b)(6) 2021, a user of the nuface trinity device reported experiencing skin related disorders on the face that the user attributed to use of the nuface device. The user reported experiencing severe skin damage to the face, including, hyperpigmentation of the skin, itchiness, heat, and pain after using the device twice on her face and neck collarbone. The user claimed she had visited multiple hospitals and dermatologists who indicated there was no treatment. The user stated she returned the product back to the distribution center who sold her the device on (b)(6) 2017. The client did not allege any potential adverse effects from the device at the time of return. No investigation on the alleged device can be performed as the return and retrieval of the device is pending. Based on the information provided, we cannot confirm that use of a nuface product caused or contributed to the health effects described by the user.
 
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Brand NameNUFACE TRINITY
Type of DeviceTRINITY
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 Key12450444
MDR Text Key270799631
Report Number3006459199-2021-00001
Device Sequence Number1
Product Code NFO
Combination Product (y/n)Y
Reporter Country CodeKS
PMA/PMN Number
K131251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
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 Received05/16/2021
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

Patient Treatment Data
Date Received: 09/09/2021 Patient Sequence Number: 1
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