FDA Adverse Event Summary report: N

TRIA LASAR

MDR report key: 3308483 · Received August 21, 2013

Report

Report Number
MW5031580
Date Received
August 21, 2013
Date of Event
August 10, 2013
Report Date
August 20, 2013
Manufacturer
TRIA BEAUTY
Product Code
GEX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

HOLD KR 8/27/13 I HAD BEEN USING THE TRIA LASER ON MY UPPER LIP. THE DIRECTIONS INCLUDED SAY TO USE IT EVERY WEEK AND RESULTS MAY BE NOTICED IN AS FEW AS THREE MONTHS. FOR THE FIRST TWO WEEKS, I USED IT ONLY ON THE UPPER LIP AFTER TESTING THE AREA AS RECOMMENDED IN THE INSTRUCTIONS. I WAS USING A LEVEL 2. BEGINNING WITH THE THIRD WEEK, I ALSO TRIED USING IT ON MY CHIN, ON A LEVEL ONE, AFTER TESTING THE AREA FIRST. THE LEVEL ONE WAS EXTREMELY PAINFUL AND I COULD ONLY USE 3 PULSES BEFORE IT BROUGHT ME TO TEARS. FOR WEEK 4, I AGAIN DID THE UPPER LIP ON A LEVEL 3 AND AGAIN TRIED THE CHIN ON A LEVEL 1, BUT HAD THE SAME PAINFUL REACTION ON THE CHIN. ON WEEK 5, I STARTED WITH THE CHIN USING A LEVEL 1. THE PAIN WAS SO BAD AFTER ONLY TWO PULSES THAT I HAD TO STOP. I SWITCHED TO THE UPPER LIP AND GOT HALFWAY THROUGH BEFORE RED BURN MARK BEGAN APPEARING ON THE UPPER LIP. I IMMEDIATELY STOPPED USING THE DEVICE. THE BURNS TURNED INTO BLISTERS OVER THE NEXT TWO DAYS, AND THEN FINALLY HEALED UP. I WAS VERY CONCERNED BECAUSE WITHIN A DAY OF THAT HAPPENING TO ME, I NOTICED A NEW TRIA AD ON TV. THE PRICE HAD NOW BEEN CUT IN HALF AND THE ADVERTISEMENT WAS SAYING YOU ONLY USE IT EVERY TWO WEEKS. I CONTACTED TRIA ABOUT THIS, AND WAS TOLD "IT IS SO EFFECTIVE YOU DO NOT NEED TO USE IT EVERY WEEK." I AM EXTREMELY CONCERNED BECAUSE FOR THEM TO CHANGE THE TIME FROM WEEKLY TO EVERY OTHER WEEK MAKES ME QUESTION THE SAFETY OF THE DEVICE. I AM WONDERING IF THEY HAVE HAD SOME NEGATIVE REACTIONS AND HAVE FOUND THAT USING IT WEEKLY IS UNSAFE. I AM WONDERING IF THEY ARE FAILING TO DISCLOSE THIS TO THE PUBLIC. NOW THAT IT HAS BEEN ON THE MARKET FOR A WHILE, PERHAPS THEY WERE FINDING IT HAS UNDESIRABLE OR EVEN DANGEROUS SIDE EFFECTS. ANOTHER RED FLAG WAS RAISED BECAUSE I POSTED A NEGATIVE REVIEW OF THE PRODUCT ON THE SITE AND WROTE OF MY EXPERIENCES WITH BEING BURNED. I RECEIVED AN EMAIL SAYING THE... I DID NOT GO TO A DOCTOR FOR THE BURNS. I USED NEOSPORIN FOR THREE DAYS AND THEY HEALED UP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
405988 TRIA LASAR TRIA LASAR GEX TRIA BEAUTY

Patients

Seq Age Sex Outcome Treatment
1 49 YR