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	Headache (1880); Pain (1994); Blurred Vision (2137); Eye Pain (4467); Swelling/ Edema (4577)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reports temple and eye pain, headaches, and blurry vision after off-label bellafill dermal filler injection in the temples, under the eyes, and on top of the eyebrows, which resulted in er visit.Per the patient, she was not treated in the er, but it was recommended she see a neurologist.The next day her vision as fine.A neurologist appointment is scheduled for (b)(6) 2021.The bellafill injector states that the patient has only mentioned swelling/edema after the injections.Additional info: injecting doctor: (b)(6).Dr.(b)(6) relays that the patient has left several voice messages and there was no mention of pain.Per dr.(b)(6), the patient relayed "too much swelling", then "too much swelling in eye area", then "her friends don't see a difference before and after injections".Dr.(b)(6) also relayed that the day after her bellafill injections the patient called to get a steroid injection for swelling.Dr.(b)(6) asked the patient to come in for exam, but the patient did not show up for the appointment, patient also subsequently reported puffiness around the eye, bruising, and dizziness to suneva.Most recently reporting nodules in the areas injected.The patient has not seen a doctor since er visit, but states she will be going back to see dr.(b)(6) for exam.She is having scheduling issues, but hopes to see dr.(b)(6) soon.A neurologist appointment is scheduled for (b)(6) 2021.At last contact, (b)(6) 2021, the patient relays that her headaches are still intense, but are less frequent in occurrence.She also states that she now has nodules.On the same day as the bellafill injections, (b)(6) 2021, the patient also received kybella on the chin and 60 units of botox in the forehead, crow's feet and end of nose.The maker of kybella and botox will be notified.The patient reports no concomitant medical conditions.Bellafill completed review of the lot number used in the patient's bellafill procedure, lot f211001.No issues were noted in manufacturing records or in retained lot samples.The patient was injected with bellafill off-label in the temples, under the eyes, and on top of the eyebrows.Per the bellafill instructions for use: 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.".
Event or Problem Description
Patient reports temple and eye pain, headaches, and blurry vision after off-label bellafill dermal filler injection in the temples, under the eyes, and on top of the eyebrows, which resulted in er visit.Per the patient, she was not treated in the er, but it was recommended she see a neurologist.The next day her vision as fine.The neurologist appointment is scheduled for (b)(6) 2021.The bellafill injector states that the patient has only mentioned swelling/edema after the 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
• MDR Report Key: 12378424
• Report Number: 3003707320-2021-00012
• Device Sequence Number: 4333885
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)220713(10)F211001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/26/2021

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: 07/13/2022
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F211001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOTOX IN FOREHEAD, CROW'S FEET, END OF NOSE; KYBELLA IN THE CHIN
• Outcome Attributed to Adverse Event: Hospitalization