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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
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
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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