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	Granuloma (1876); Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported medwatch (b)(4) received on 03/15/2024 with health effects of 1876: granuloma and 2360: deformity/disfigurement after artefill/bellafill dermal filler injection.Outcomes attributed to adverse event include: required intervention, other serious or important medical event, and disability or permanent injury.No patient or doctor contact information was provided.
Additional Manufacturer Narrative
Patient reported medwatch (b)(4) received on 03/15/2024 with health effects of 1876: granuloma and 2360: deformity/disfigurement after artefill/bellafill dermal filler injection.Outcomes attributed to adverse event include: required intervention, other serious or important medical event, and disability or permanent injury.No patient or doctor contact information was provided.B3: date of event: unknown.D1: brand name: the description of event in (b)(4) includes both bellafill and artefill, which are different brand names for the same product, bellafill being the most recent.D4: additional device information: the bellafill model number is gbf0508.The artefill model number is af0508.Lot numbers were not provided and are unknown.D5: operator of device: the medwatch report did not provide injector information; however, bellafill is sold only to medical professionals.E1: reporter name and address: the patient reported via medwatch.No names, initials, or contact information were provided.E3: occupation: it is suspected that the patient is a non-health professional, but that information is unknown.H6: investigation - medical device problem code: the patient describes bellafill/artefill injections in both "smile lines" and "minuette lines".It cannot be confirmed, but it is suspected that they meant the nasolabial folds and marionette lines, respectively.Marionette lines are off-label for bellafill.No patient or doctor contact information was provided.No artefill or bellafill lot numbers were provided.Suneva medical is unable to proceed with the investigation without additional info.Artefill (now 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.Artefill (now 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.".

• 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 ; 8587685492
• MDR Report Key: 19098216
• Report Number: 3003707320-2024-00003
• Device Sequence Number: 13710043
• Product Code: LMH
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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 Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Disability; Other
• Patient Sex: Female