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

Model Number	GBF0508
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2023, the bellafill dermal filler provider reported a patient with suspected occlusion after injection in acne scars on the cheeks.Injection date was on (b)(6) 2023.Medical intervention was provided: the patient completed 10 sessions of hyperbaric chamber treatments along with valtrex, bactrim ds, and viagra medications.At last contact on (b)(6) 2023 the patient is doing much better.Additional info: date of event: on (b)(6) 2023.This was the initial report date to suneva medical.Actual date of event is unknown.Patient injected with bellafill on (b)(6) 2023 and the patient had normal edema/erythema during the injection.Potential occlusion was reported to suneva on 03/03/2023 at the time of the original report.Device available for evaluation: bellafill syringes are single use devices that are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit." "investigation findings" - no issues were found with the bellafill dermal filler lot used in the patient's procedure.Manufacturing records indicated the lot met all acceptance criteria upon release and review of retained lot samples found the lot continued to meet release criteria.'medical device problem code' and 'investigation conclusions': initial reporter indicated a subscision technique was done while injecting bellafill dermail filler for acne scarring.The subscision is suspected to have contributed to the initial symptoms of edema/erythema and report of suspected occlusion.Per bellafill instructions for use: ".Injection for acne scar can use both the retrograde linear threading and serial puncture techniques." discussions with suneva medical affairs advisor confirmed that typical symptoms of an occlusion with bellafill injections occur imediately upon injection, and include an immediate blanching or whitening of the skin and associated skin pain, which was not reported to have occurred with this patient.
Event or Problem Description
On (b)(6) 2023, the bellafill dermal filler provider reported a patient with suspected occlusion after injection in acne scars on the cheeks.Injection date was on (b)(6) 2023.Medical intervention was provided: the patient completed 10 sessions of hyperbaric chamber treatments along with valtrex, bactrim ds, and viagra medications.At last contact on (b)(6) 2023 the patient is doing much better.

• 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
• Manufacturer (Section G): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego CA 92121
• Manufacturer Contact: pam misajon ; 5870 pacific center blvd.; san diego, CA 92121 ; 8588290768
• MDR Report Key: 16659875
• Report Number: 3003707320-2023-00007
• Device Sequence Number: 11210038
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)230804(10)F221010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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: 08/04/2023
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F221010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female