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

Model Number	GBF0508
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient relayed deformation to the doctor about 2 weeks after bellafill injection, but will not allow the doctor to examine to determine cause or diagnosis.Patient states they require surgery to correct.Timeline: on (b)(6) 2020: the patient was injected with bellafill dermal filler in the "marionette lines, jowls, and parenthesis lines".On (b)(6) 2020: the patient reported the deformation to the doctor.The actual onset date is unknown.The area(s) of "deformation" is unknown.On (b)(6) 2020: date the issue was reported to (b)(6).Known patient medical history per the reporting account: patient states no known medical conditions.No known drug allergies.Currently takes no medications.No other fillers or facial treatments per the injector's knowledge.The lot used in the patient's bellafill procedure (lot f191096) was reviewed.No issues were noted with manufacturing records, the lot met all acceptance criteria upon release.Review of the retained lot samples for lot f191096 found the lot continues to meet release criteria.The patient has refused to come back to the injector for examination as of the date of this submission.The cause of the reported deformation is unknown.The patient was injected with bellafill dermal filler in the "marionette lines, jowls, and parenthesis lines".The area(s) of "deformation" is unknown.Bellafill dermal filler is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.Bellafill syringes are single use devices and are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit.".
Event or Problem Description
Patient relayed deformation to the doctor about 2 weeks after bellafill injection, but will not allow the doctor to examine to determine cause or diagnosis.Patient states they require surgery to correct.

• Brand Name: BELLAFILL DERMAL FILLER
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego, ca
• MDR Report Key: 9832865
• Report Number: 3003707320-2020-00004
• Device Sequence Number: 764898
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)210317(10)F191096
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2021
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F191096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention