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	Unspecified Infection (1930)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported infection that requires medical intervention after off-label bellafill dermal filler injection in the neck lines.
Additional Manufacturer Narrative
Patient reported infection that requires medical intervention after off-label bellafill dermal filler injection in the neck lines.Patient indicates her doctor (a plastic surgeon) is suggesting surgery to remove the product since she now has an infection "from it".She also says that another doctor has suggested oral and topical antibiotics for 30 days to avoid surgery.The patient has not provided the names or contact information of any of her providers who have suggested these interventions, so at this point there are no other avenues for this investigation.B3: date of event: 04/23/24 - this is the date that infection and needed medical intervention were relayed by patient to suneva medical.D8 and d9: bellafill dermal filler syringes are single use devices and are meant to be discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit." the bellafill dermal filler injector was: (b)(6).Review of the lot used in the patient's procedure found no issues in manufacturing review or in retained lot samples.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.

• 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: stacy lewis ; 5870 pacific center blvd.; san diego, CA 92121 ; 8584446876
• MDR Report Key: 19384157
• Report Number: 3003707320-2024-00005
• Device Sequence Number: 4071429
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)250214(10)F231057
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 02/14/2025
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F231057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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