FDA Adverse Event Malfunction Summary report: N

ELEVARE PLUS

MDR report key: 10875341 · Received November 19, 2020

Report

Report Number
MW5097995
Event Type
Malfunction
Date Received
November 19, 2020
Date of Event
December 9, 2018
Report Date
November 17, 2020
Manufacturer
ELEVARE SKIN / OMM IMPORTS, INC. D/B/A ZERO GRAVITY
Product Code
OHS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I PURCHASED AN ELEVARE PLUS MEDICAL SKIN DEVICE FOR NEARLY (B)(6) FROM OCEAN BEAUTY (AN AUTHORIZED RESELLER OF ELEVARE) AT A SHOW IN (B)(6) IN (B)(6) 2018. I IMMEDIATELY GOT HOME AND REGISTERED MY PRODUCT WITH ELEVARE. THE REASON I PURCHASED THIS UNIT IS BECAUSE THE DEMONSTRATOR UNIT WORKED IMMEDIATELY AND SHOWED INSTANT RESULTS IN MY FROWN LINES. I GOT THE NEWLY PURCHASED UNIT HOME AND STARTED USING IT AS INSTRUCTED. HOWEVER, NOT ONLY DID I NOT GET THE SAME RESULT AS THE DEMONSTRATION UNIT, IT HAS BEEN 2 YEARS AND THERE IS NO IMPROVEMENT WHATSOEVER IN MY FROWN LINES OR ELSEWHERE ON MY FACE THAT I HAVE USED THIS PRODUCT. I CONTACTED ELEVARE CUSTOMER CARE EARLY ON BECAUSE I THOUGHT MAYBE I HAD A BAD UNIT AND WAS TOLD SIMPLY, "IF THE RED LIGHT IS ON, THE DEVICE IS WORKING." I WAS ALSO TOLD IT COULD TAKE UP TO 6 WEEKS TO SEE RESULTS. I CONTINUED USING THE PRODUCT AS INSTRUCTED. WITHIN A FEW MONTHS OF PURCHASE, CONTACTED THE RESELLER'S CONSULTANT VIA EMAIL AND SHE GAVE ME SOME TIPS AND TRICKS. STILL NO RESULT. A FEW MONTHS LATER, SHE AUTHORIZED AN EXCHANGE AS THEY HAVE A NO REFUND POLICY. THE NEW UNIT HUMMED WHEN THE RED LIGHT WAS ON BUT STILL CAME UP EMPTY ON THE RESULTS. I CONTACTED THE CONSULTANT AGAIN AND AGAIN FOR ASSISTANCE AND WHILE SHE WAS VERY GRACIOUS, NOTHING HELPED. THE LAST TIME I CONTACTED HER WAS FOR A REFUND AND SHE STOPPED RESPONDING TO ME. I CONTACTED ELEVARE CUSTOMER CARE AGAIN AND WAS TOLD "IT CAN TAKE UP TO A YEAR TO SEE RESULTS." I EVENTUALLY PAID A FEE TO EXCHANGE THE UNIT UNDER WARRANTY THRU ELEVARE AND YET AGAIN, GOT A UNIT THAT HASN'T PRODUCED ANY RESULTS IN MY SKIN WHATSOEVER. WHAT CONCERNS ME IS THREE FOLD: WHY, IF THE DEMONSTRATION UNIT PRODUCED INSTANT RESULTS, DID THE UNIT I PURCHASE NOT OPERATE IN THE EXACT SAME MANNER AS THE DEMONSTRATOR?; AND WHY IS ELEVARE CUSTOMER CARE TELLING PEOPLE IT CAN TAKE "UP TO 6 WEEKS" TO SEE RESULTS AND THEN "UP TO A YEAR"?; AND THE RESELLER HAS A NO REFUND POLICY FOR A REASON. THEY KNOW THIS IS A SCAM AND THAT THESE UNITS THEY ARE SELLING DON'T WORK. THIS WAS AN AUTHORIZED RESELLER, SO THEY MUST BE GETTING THEIR STOCK FROM ELEVARE DIRECTLY. THAT IS WHY I AM FILING THIS COMPLAINT AGAINST ELEVARE. THEY ARE SELLING PRODUCT THRU RESELLERS THAT JUST FLAT OUT DON'T WORK. I AM NOW OUT NEARLY (B)(6) WITH NOTHING TO SHOW FOR IT. I WOULD LIKE MY MONEY BACK. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1338031 ELEVARE PLUS LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS ELEVARE SKIN / OMM IMPORTS, INC. D/B/A ZERO GRAVITY ELEVARE PLUS
1338032 ELEVARE PLUS LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS ELEVARE SKIN / OMM IMPORTS, INC. D/B/A ZERO GRAVITY ELEVARE PLUS
1338033 ELEVARE PLUS LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS ELEVARE SKIN / OMM IMPORTS, INC. D/B/A ZERO GRAVITY ELEVARE PLUS

Patients

Seq Age Sex Outcome Treatment
1 52 YR