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

Model Number	GBF0208
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported allergic reaction after off-label bellafill dermal filler injection in the chin area, resulting in er visit and medication intervention.The patient did not have the required skin test prior to the bellafill dermal filler injections.Patient relays that her symptoms were tightening in her throat, coughing due to the tightness, and headaches.Additional patient symptoms that were relayed by the injector were chest tightness and difficulty swallowing.Thepatient went to the er which provided benedryl and iv steroids and told her she was having an allergic reaction.They also prescribed 5-day oral steroids which she started as of (b)(6) 2024 and reported she was doing a bit better at that time.The bellafill dermal filler injector was: (b)(6).The bellafill skin test is required prior to bellafill injections per the bellafill dermal filler and bellafill skin test ifus.Per the patient, she was told by the injector that a skin test prior to injections was not required.The injector relays that the patient declined the skin test.Injector relays via phone call on (b)(6) 2024, at last contact with the patient via patient provided photo there were no outward signs of an allergic reaction.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.Bellafill dermal filler 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.".
Event or Problem Description
Patient reported allergic reaction after off-label bellafill dermal filler injection in the chin area, resulting in er visit and medication intervention.The patient did not have the required skin test prior to the bellafill dermal filler injections.

• 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: 19117119
• Report Number: 3003707320-2024-00004
• Device Sequence Number: 20722545
• Product Code: LMH
• UDI-Device Identifier: 20350224000022
• UDI-Public: (01)20350224000022(17)250520(10)F231070
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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: 05/20/2025
• Device Model Number: GBF0208
• Device Catalogue Number: GBF0208
• Device Lot Number: F231070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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