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 Code	Nodule (4551)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02/28/2023, the bellafill dermal filler provider reported that a patient with nodules after off-label bellafill injection in the neck requires surgery to resolve.Surgery occurred in (b)(6) 2023.At last contact on 03/30/2023 the patient is doing well.
Additional Manufacturer Narrative
On 02/28/2023, the bellafill dermal filler provider reported that a patient with nodules after off-label bellafill injection in the neck requires surgery to resolve.Surgery occurred in (b)(6) 2023.At last contact on (b)(6) 2023 the patient is doing well.Date of event = (b)(6) 2021.This is the approximate date the patient first noticed the nodules.Patient indicates she developed the nodules in her neck about 8 months after her necklift surgery of (b)(6) 2021.Bellafill was injected off-label by the surgeon during the necklift.Explant date=(b)(6) 2023.This is the approximate date.The reporting account indicated that the surgery was done in (b)(6) 2023.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." 'type of investigation': no issues were noted with review of the manufacturing records for the lot used in the patient's procedure.Retained samples were not available as the product was expired at the time of the initial report.Expiration date: 09/10/2021.'medical device problem code' and 'investigation conclusions': bellafill 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.

• 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: 16649874
• Report Number: 3003707320-2023-00006
• Device Sequence Number: 5340425
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)210910(10)F201020
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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: 09/10/2021
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F201020
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• 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 Age: 61 YR
• Patient Sex: Female