MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. ARTEFILL - NOW BELLAFILL; IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problems Foreign Body Reaction (1868); Scarring (2061); Swelling (2091); Reaction (2414)

Event Date 08/31/2017

Event Type  Injury  

Event Description

Three surgeries and disfigurement.I was injected with artefill nine years ago and a very reputable hospital in (b)(6) by an internationally renown plastic surgeon.I did not pay for this product but was injected as a pharmaceutical representative friend of mine instructed the doctor on how to inject the product.I had a delayed reaction where my face/lips were swollen beyond recognition.The product was never approved and always contraindicated for the lips.After a biopsy was performed from inside my bottom lip it was confirmed that i was having a giant cell foreign body reaction to artefill.The company's own literature establishes they knew their product was known to cause problems with patients that had autoimmune issues which is partially the reason it has been rebranded three times.They will not provide me any assistance with all of my out of pocket expenses or for the fact that i am now disfigured and my lips do not function.There is permanent scarring on my face from surgery to try to remove the artefill.My lips hurt 24/7 and there is nothing that can be done.Suspect: yes.Primary: yes.Product type: drug/biologic.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Did the problem return if the person started taking or using the product again: yes.Quantity: 1 injection.How was it taken or used: subcutaneous.Therapy duration: 1 year.Why was the person using the product: to train doctors how to inject the product.

• Brand Name: ARTEFILL - NOW BELLAFILL
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.
• MDR Report Key: 7467790
• MDR Text Key: 106954673
• Report Number: MW5076812
• 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: Other
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 63