MAUDE Adverse Event Report: TRIA BEAUTY TRIABEAUTY AGE-DEFYING LASER

Model Number AGE-DEFYING LASER

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.

• Brand Name: TRIABEAUTY AGE-DEFYING LASER
• Type of Device: TRIABEAUTY AGE-DEFYING LASER
• Manufacturer (Section D): TRIA BEAUTY
• MDR Report Key: 3748452
• Report Number: MW5035598
• Device Sequence Number: 1
• Product Code: GEX
• 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 Received: 04/09/2014
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: AGE-DEFYING LASER
• OTHER Device ID Number: SRL SN 015431873

Patient TREATMENT DATA

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