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	Swelling/ Edema (4577)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical intervention and hospitalization for severe swelling after off-label bellafill injection in the cheeks.Per patient she resolved 5 days after onset.
Additional Manufacturer Narrative
Medical intervention and hospitalization for severe swelling after off-label bellafill injection in the cheeks.Per patient she resolved 5 days after onset.Per patient: she has had bellafill dermal filler previously with no issues.Injection date was (b)(6) 2023 and severe swelling occurred that evening.She went to the hospital on (b)(6) 2023 and received iv steroids, prednisone pack, and benedryl.She resolved 5 days after onset (b)(6) 2023.Bellafill provider: dr.(b)(6).Subsequent statements provided by the bellafill provider's office: the patient, (b)(6), dob (b)(6) 1986 has had a total of 17 syringes of bellafill beginning (b)(6) 2018.After syringe #16 the patient had mild facial swelling and dr.(b)(6) prescribed a medrol pack.She was scheduled on (b)(6) 2023 for syringe #17 and dr.(b)(6) prescribed a medrol pack for her to take prior to this injection.It did not work.The patient sought medical attention and was given iv steroids, she states she did not have difficulty breathing.Both the 16th and 17th syringes were from the same bellafill dermal filler lot f231017.Manufacturing records and retained lot samples from lot f231017 were reviewed with no issues noted.Bellafill.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.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: 17713108
• Report Number: 3003707320-2023-00012
• Device Sequence Number: 14015923
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)240913(10)F231017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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: 09/13/2024
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F231017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female