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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIA BEAUTY TRIABEAUTY AGE-DEFYING LASER
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TRIA BEAUTY TRIABEAUTY AGE-DEFYING LASER Back to Search Results
Model Number AGE-DEFYING LASER
Device Problem Insufficient Information (3190)
Patient Problems Dehydration (1807); Peeling (1999); Skin Discoloration (2074); No Code Available (3191)
Event Date 03/26/2014
Event Type  Injury  
Event Description

I used the triabeauty at home anti-aging, non-ablated fraxel laser on my face for the treatment of wrinkles according to the instructions. I used the laser the night before the event and was fine the next morning. The morning after using it the second time, i noticed severe darkening and dehydration of my skin. I had a yellowish brownish spots on my face. I also had deep dark maroon lines on either side of my mouth. I stopped using the laser immediately. I contacted the manufacturer and requested to speak with a dermatologist or have them refer me to one. They did not respond with a referral, even though i sent photos of my skin. Also, i noticed that the dark maroon lines around my mouth continued to darken, get larger, and more severely dry throughout the week. I was applying neosporin to treat it. I stopped by my local (b)(6) clinic and they gave me skin lightening cream. I used this for only 2 days, as my skin's dryness and peeling went into 'hyper mode. ' i also noticed that my eyelids and rings underneath my eyes became severely darkened.

 
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Brand NameTRIABEAUTY AGE-DEFYING LASER
Type of DeviceTRIABEAUTY AGE-DEFYING LASER
Manufacturer (Section D)
TRIA BEAUTY
MDR Report Key3748452
MDR Text Key4549248
Report NumberMW5035598
Device Sequence Number1
Product Code GEX
Combination Product (Y/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 04/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberAGE-DEFYING LASER
OTHER Device ID NumberSRL SN 015431873

Patient TREATMENT DATA
Date Received: 04/09/2014 Patient Sequence Number: 1
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