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	Unspecified Infection (1930)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Doctor reported a patient with infection which required treatment to resolve after off-label injection of bellafill dermal filler in the left lower cheek.The doctor relays that the patient is doing well now when they saw her last in early (b)(6) 2021.Additional info: per the injecting physician, she always preps the skin with alcohol and no other sites that she injected with bellafill on this patient on that day had a problem.The infection was only noted in the left lower cheek.When the patient presented with erythema, pain and apparent fluctuance under the skin, she drained the area with an 18g puncture wound and got back about 1 cc of purulent material.Unfortunately she was not able to culture the material as she does not carry culturettes in her office.She started the patient on a course of augmentin at that time.The next day she saw the patient and the area appeared better but out of an abundance of caution, she performed a proper incision and drainage with a 1 cm incision but did not see any more pus.The patient reports no concomitant medical conditions.As of ~08/5/2021, the patient is doing well.Bellafill completed review of the lot number used in the patient's bellafill procedure, lot f211013.No issues were noted in manufacturing records or in retained lot samples.The patient was injected with bellafill off-label in the left lower cheek.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
Doctor reported a patient with infection which required treatment to resolve after off-label injection of bellafill dermal filler in the left lower cheek.The doctor relays that the patient is doing well now when they saw her last in early (b)(6) 2021.

• 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: 12379966
• Report Number: 3003707320-2020-00013
• Device Sequence Number: 19916911
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)220817(10)F211013
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: 08/17/2022
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F211013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR