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

Model Number AF0508

Device Problems Biofilm coating in Device (1062); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Doctor reports suspected biofilm, which requires treatment to resolve, around foreign body granuloma after artefill dermal filler injection.Granuloma (confirmed via biopsy) was excised at patient request after prior treatments with oral antibiotics and steroids.Biofilm could not be confirmed.At last contact, the patient is healing well after excision.Timeline: (b)(6) 2011: the patient was injected with artefill dermal filler in the on-label in the nasolabial folds.(b)(6) 2013: granuloma onset.Per injector the patient had been subsequently treated for years with oral antibiotics and steroids.The granulomas would always get better but would return when the injections stopped.The doctor suspected an occult infection.(b)(6) 2018: diagnosed and successfully treated a subclinical dental abscess which had been present for several years.Granuloma did not resolve.(b)(6) 2020: granuloma removed at patient request and a biopsy conducted which confirmed foreign body granuloma.Doctor also suspects biofilm at this time.(b)(6) 2020: the doctor indicates the patient is healing well after excision.Patient medical history: had subclinical dental abscess for several years which was then diagnosed and treated successfully in december 2018 after granuloma began.No other fillers in the nl folds she also developed sculptra granulomas of pre jowl area in july 2015.These resolved completely no other significant medical issues.The artefill lot used in the patient's procedure (f101025) was reviewed.The lot was manufactured according to approved work instructions and met all acceptance criteria upon release.The lot has since expired (as of 12/31/2011) therefore retained lot samples are not available for review.This is the first report of suspected biofilm and the first report of granuloma for lot f101025.At the time of the injections, artefill dermal filler was indicated for the correction of nasolabial folds.The artefill (now bellafill) ifu contains the following precaution: "as with all transcutaneous procedures, artefill (now bellafill) injection carries a risk of infection.The usual precautions associated with injectable materials should be followed." artefill (now bellafill) syringes are single use devices and are typically discarded after use.Per the artefill (now bellafill) ifu: "the syringe and any unused material should be discarded after a single treatment visit." granuloma is an anticipated patient event that is documented in the artefill (now bellafill) ifu.Clinical studies support that granuloma may resolve over time with or without treatment.

Event Description

Doctor reports suspected biofilm, which requires treatment to resolve, around foreign body granuloma after artefill dermal filler injection.Granuloma (confirmed via biopsy) was excised at patient request after prior treatments with oral antibiotics and steroids.Biofilm could not be confirmed.At last contact, the patient is healing well after excision.

• Brand Name: ARTEFILL DERMAL FILLER
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego, ca
• Manufacturer (Section G): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego, ca
• Manufacturer Contact: stacy lewis ; 5870 pacific center blvd.; san diego, ca ; 7685492
• MDR Report Key: 9741118
• MDR Text Key: 190048786
• Report Number: 3003707320-2020-00002
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2011
• Device Model Number: AF0508
• Device Catalogue Number: AF0508
• Device Lot Number: F101025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR