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

Model Number	GBF0508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Nodule (4551); Swelling/ Edema (4577)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, patient relays she recently returned home after 5 days in the icu due to severe swelling and suspected allergic reaction to bellafill dermal filler.Per the bellafill injector, the patient was injected in both nasolabial folds and also indicates patient has nodules in the nasolabial folds and marked edema on the left side.
Additional Manufacturer Narrative
On (b)(6) 2022, patient relays she recently returned home after 5 days in the icu due to severe swelling and suspected allergic reaction to bellafill dermal filler.Per the bellafill injector, the patient was injected in both nasolabial folds and also indicates patient has nodules in the nasolabial folds and marked edema on the left side.Date of event: (b)(6) 2022 is the approximate date of hospitalization noted as about " a week or so ago" per patient statement dated (b)(6) 2022.Biopsy indicated inflammation consistent with a dermal filler; however no pmma microspheres were noted in the tissue.Pmma is a non-resorbable ingredient in the bellafill dermal filler.The initial reporter was the patient, initials (b)(6).Additional info: patient's bellafill dermal filler injector: (b)(6).Patient's current swelling is on one side of the face (left side), while she was injected in both nasolabial folds.No issues were noted with review of manufacturing records for the lot used in the patient's procedure.The lot has since expired therefore retained samples were not available for review.A skin test is required 4 weeks prior to bellafill dermal filler treatment to determine patient's suitability for bellafill treatment.It has not been confirmed whether a skin test was done prior to treatment.In addition, lidocaine and collagen are both resorbed by the body not long after injection.Llidocaine soon after injection and collagen is resorbed in about a few months.The patient was injected about 2 years ago on (b)(6) 2020.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.Nodules and swelling are anticipated patient events that are documented in the bellafill ifu.Clinical studies support that these issues may resolve over time with or without treatment.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: 15983576
• Report Number: 3003707320-2022-00009
• Device Sequence Number: 17551838
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)210604(10)F191120
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: 06/04/2021
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F191120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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: Hospitalization
• Patient Sex: Female