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

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.

• Brand Name: TRIABEAUTY AGE-DEFYING LASER
• Type of Device: TRIABEAUTY AGE-DEFYING LASER
• Manufacturer (Section D): TRIA BEAUTY
• MDR Report Key: 3748452
• MDR Text Key: 4549248
• Report Number: MW5035598
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 63