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

Model Number	GBF0508
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient presenting with severe swelling in face and neck on (b)(6) 2021, the day after injection of 1 syringe of bellafill dermal filler off-label in the cheeks on (b)(6) 2021.Injecting account states they had to send the patient to urgent care where they received treatment.The patient has since resolved.Two months prior to the injections of (b)(6) 2021 (and subsequent severe swelling on (b)(6) 2021), the patient had 2 syringes of bellafill without issues.As such, it is believed that it is unlikely that bellafill is the cause of the patient's severe swelling.The injecting account states that when the patient presented on (b)(6) 2021 with severe swelling, the face was fully swollen and the neck was starting to swell.No difficulty breathing, vitals were normal.No difficulty in vision.They state they had to send her to urgent care where she received a steroid injection and a steroid prescription.As of (b)(6) 2021, the account reports that the patient has fully recovered.Bellafill completed review of the lot number used in the patient's bellafill procedure, lot f211017.No issues were noted in manufacturing records or in retained lot samples.The patient was injected with bellafill off-label in the cheeks.Per the bellafill instructions for use: 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 presenting with severe swelling in face and neck on (b)(6) 2021, the day after injection of 1 syringe of bellafill dermal filler off-label in the cheeks on (b)(6) 2021.Injecting account states they had to send the patient to urgent care where they received treatment.The patient has since resolved.

• 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 92121
• MDR Report Key: 12029314
• Report Number: 3003707320-2021-00007
• Device Sequence Number: 17210754
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)220903(10)F211017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 09/03/2022
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F211017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/18/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 50 YR