MAUDE Adverse Event Report: SUNEVA MEDICAL INC. ARTEFILL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Deformity/ Disfigurement (2360); Reaction (2414)

Event Date 06/01/2016

Event Type  Injury  

Event Description

I received artefill.Brand facial injections in (b)(6) 2015.The injections were administered by dr.(b)(6), owner of (b)(6): (b)(6).It is my understanding that artefill contains microscopic particles of plastic that stimulates natural growth of collagen at injection sites, and that the treatment lasts 5 years or longer.I experienced an adverse reaction to the treatments within the first year, developing large lumps of what i understand are nodules of collagen, at the injection sites.The lumps were large and disfiguring.The injection sites are along my upper lip, and "smile lines," under the eyes, and along the brow line.At one point the lumps were so pronounced that i was unable to open my mouth far enough for a dental exam.I have been receiving treatments at no charge from dr (b)(6) that i understand is a substance that dissolves collagen.To date, i have received over 30 treatments of about 10 painful facial injections each.The treatments are on-going, and i understand they may need to continue up to 2 years longer.Dr (b)(6) notified artefill who claimed they had never heard about the problem.They minimized the issue.In emails they referred to my reaction as "(b)(6) lump", and they offered no treatment strategies nor have they agreed to reimburse dr (b)(6) for my treatments.Further, one of dr (b)(6) colleagues had a pt with the same reaction.Artefill learned that this physician planned to give a talk on the problems with artefill at a medical doctor's meeting, and they threatened to sue the doctor.The doctor proceeded, and, as far as i know, artefill did not sue.Dr (b)(6) hinted to me that "some pt should complain to the fda." i think he fears financial or legal redress on the part of artefill."how was it taken or used: subcutaneous; did the problem stop after the person reduced the dose or stopped taking or using the product: no." aesthethic treatment.

• Brand Name: ARTEFILL
• Type of Device: ARTEFILL
• Manufacturer (Section D): SUNEVA MEDICAL INC.
• MDR Report Key: 6922161
• MDR Text Key: 88913731
• Report Number: MW5072638
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 81