MAUDE Adverse Event Report: ELEVARE SKIN / OMM IMPORTS, INC. D/B/A ZERO GRAVITY ELEVARE PLUS; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Model Number ELEVARE PLUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2018

Event Type  malfunction  

Event Description

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).

• Brand Name: ELEVARE PLUS
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• Manufacturer (Section D): ELEVARE SKIN / OMM IMPORTS, INC. D/B/A ZERO GRAVITY
• MDR Report Key: 10875341
• MDR Text Key: 217679337
• Report Number: MW5097995
• Device Sequence Number: 1
• Product Code: OHS
• 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: 11/17/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ELEVARE PLUS
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 73