Suneva Medical Inc

Revdex.com:
I have reviewed the response made by the business in reference to complaint ID ***, and have determined that this proposed action would not resolve my complaint. For your reference, details of the offer I reviewed appear below
Regards,*** ***
Suneva Medical made a statement in regards to a demand letter asking for $100,000, this is completely falseI have copies of any and all letters sent to the company and the demand was one forth of that amount.The third party they are referring to is the doctor in their hire, who is the Artefill instructor for all of Tennessee, and also a close personal friend of their sales representative, I have emails from *** *** to prove these statements.Suneva Medical intentionally mislead meI delayed legal action because I was hopeful I was going to receive treatment, but this was only a ruse on their part to allow the statute of limitations to run out to file suit against their company. I was never unreasonable in my request to the company, I only ask them for correction to my appearance and treatment to relieve the physical symptoms of the infection caused by their product. I still have clumps of product where I was injected and numbness in that area and was told by my family physician that I may have permanent nerve damage from the Artefill injectionsThis company was unsympathetic to my ordeal, they completely ignored my plea for helpThe only reason they have responded now is because of the ratingPlease do no allow them to sweep this incident under the rug, there should be some kind of accountabilty so they connot do this to someone else who has a problem with their product in the futureI am willing to send the documentation to prove that my statements are trueI also welcome Suneva to provide the same documentsThanks

On behalf of Suneva Medical, Inc. I write in response to your letter of November 4, 2014 concerning your complaint ID [redacted] 
First, I apologize for the delayed response and I appreciate your giving us...

the opportunity to be heard. Before addressing the specifics of this complaint, a bit of background regarding Suneva Medical. We have been in business since April 2009 are an FDA licensed and regulated manufacturer of medical devices. As such we are required to maintain rigorous quality control and complaint handling procedures. We are audited for compliance frequently by both the FDA and standards bodies like ISO and have an excellent record. Our lead dermal filler product, Artefill (renamed Bellafill as of 12/01/14) was approved for sale in the US by the FDA in October of 2006, has been injected in over 50,000 patients, has an admirable safety record and has never been the subject of a recall. All of the above can be verified by searching the FDA’s website at www.fda.gov.
Regarding Ms. [redacted], we have a thorough complaint file resulting from our investigation of her complaint. To put it succinctly, we determined from our retained samples that there were no quality issues with the manufacturing lot of Artefill that contained the syringes with which she was injected. With her consent, we also had a third-party physician examine her and her records and found her claim of a product defect and resulting injury to be without merit. All of this was communicated to Ms. [redacted] in a November 11, 2013 letter (attached) that we sent in response to her demand that we pay her something on the order of $100,000. 
We recognize and appreciate the role of the Revdex.com and understand that its purpose is not to arbitrate disputes, but rather to ensure dissatisfied customers are heard and given a fair response. Here we believe we have done so and respectfully request that you adjust our rating accordingly.
I’m happy to address any further questions at your convenience. 
 
[redacted]
Vice President & General Counsel
O[redacted]F[redacted]E[redacted]5383 Hollister Ave., Ste. 100, Santa Barbara, CA 93111

Review: I was injected with Artefill to correct marionette lines. Within one month there was no sign of improvement and I began having continuing problems. Opening my mouth wide was difficult and when I yawned it felt like something was pulling or tearing. I had a weird sensation and constant numbness. I still have numbness and clumps of product where the Artefill was placed. I suffered with a painful infection and graduloma in the area of my face where the Artefill was injected, and many weeks I was unable to eat properly and lost ten pounds during that time. I suffered embarrassment in my daily life the continuing problems and not being able to correct this has caused me extreme loss of confidence and low self esteem. I have contacted the company several times with this complaint and also sent a demand letter in the hopes that I would be taken seriously. I talked via email with [redacted] and also [redacted]. I was told by Ms [redacted] that I needed to visit an Artefill doctor to assess the problems I was having and find a solution. I was told that Dr [redacted], who I wanted to do the evaluation was unavailable and I was sent to Dr. [redacted] whom I am told was recommended because he is a personal friend of their Sales Representative, I have the email from [redacted] stating this. Dr. [redacted] did not address any of my symptoms and interrupted me several times during the consultation when I tried to ask questions, dismissing my concerns completely and talked mostly about himself and his career. Dr. [redacted] also informed me that he is the instructor for all Artefill injectors in Tennessee, and also trained the injector at Snooty Spa where I was injected. I was lead to believe I would receive treatment to correct the damage but this was only a ruse to delay legal action on my part until the statute of limitations had passed. I was mislead by Suneva and their C.O.O [redacted] as they intentionaly lead me believe I would recieve help to correct these problems in an attemp to delay any legal action on my part as they did not respond until the statute of limittions had passed and sent a letter by mail the day before rejecting my claim, and afterward I was complelely ignored by the company.Desired Settlement: Correction-The cost of correction is $3700

Business

Response:

On behalf of Suneva Medical, Inc. I write in response to your letter of November 4, 2014 concerning your complaint ID [redacted]