FDA Adverse Event Injury Summary report: N

OPATRA SYNERGY

MDR report key: 8744437 · Received June 28, 2019

Report

Report Number
MW5087692
Event Type
Injury
Date Received
June 28, 2019
Date of Event
April 4, 2019
Report Date
May 1, 2019
Manufacturer
OPATRA LTD.
Product Code
ILY
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I PURCHASED EYE CREAM FROM (B)(6) (I WAS ON VACATION). THE PHYSICIAN ((B)(6), DERMATOLOGIST) WORKING THERE INVITED ME FOR A FREE FACIAL. I WENT FOR MY FACIAL AND HE PROCEEDED TO USE SOME ADORE CREAMS AND OPATRA DEVICES ON ME (I REALIZED AFTER, THAT THIS WASN'T A FACIAL BUT A SALES TACTIC). I BROKE OUT IN A RASH/SWELLING ON MY FACE AND NECK LATER THAT DAY AND IT REQUIRED MEDICAL INTERVENTION (BENADRYL). CONTACTED THE DR AND HE CAME TO MY HOTEL TO SEE THE RASH. HE ASKED ME TO COME BACK TO THE STORE THE FOLLOWING DAY AND I COMPLIED. HE OFFERED ANOTHER FACIAL TO HELP WITH THE WELTS AND BUMPS. I DECLINED HIS OFFER BECAUSE I WAS AFRAID THAT I MIGHT HAVE ANOTHER REACTION. I ASKED HIM WHY HE DIDN'T ASK ME TO READ AND SIGN AN INFORMED CONSENT BECAUSE, IF I HAD, I COULD HAVE READ ABOUT THE SIDE EFFECTS/ RISKS AND I COULD HAVE MADE AN INFORMED DECISION AS TO WHETHER OR NOT I WANTED HIM TO USE THESE PRODUCTS ON ME. AS OF (B)(6) 2019, I STILL HAVE AN UNUSUAL MARK, SLIGHTLY RAISED, PINKISH, TEAR DROP SHAPED MARKS UNDER MY LEFT EYE. I REACHED OUT TO HIM AND THEIR CORPORATE OFFICE SINCE RETURNING FROM VACATION REQUESTING INFO ON SIDE EFFECT PROFILE OF PRODUCTS AND THE REFUND PROCESS BUT I HAVE NOT RECEIVED ANY SAFETY INFO. I THOUGHT THIS WOULD BE EASILY ACCESSIBLE ONLINE BECAUSE HE SAID PRODUCTS ARE FDA APPROVED BUT I COULDN'T FIND ANYTHING ON THEIR WEBSITE OR THE FDA WEBSITE. SINCE, I HAVE LOOKED FOR INFO ON ADORE ORGANIC COSMETIC AND HAVE FOUND THAT, IN 2018, THE COMPANY SETTLED A CLASS ACTION LAWSUIT FOR FALSE CLAIMS AND DECEPTIVE PRACTICES. THE FALSE CLAIMS LISTED IN THE CLASS ACTION LAWSUIT WERE SIMILAR TO THE CLAIMS THEY USED DURING THEIR SALES PITCH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
536676 OPATRA SYNERGY LAMP, INFRARED, THERAPEUTIC HEALING ILY OPATRA LTD.
536677 OPATRA SYNERGY NECK LAMP, INFRARED, THERAPEUTIC HEALING ILY OPATRA LTD.

Patients

Seq Age Sex Outcome Treatment
1 56 YR Other