MAUDE Adverse Event Report: TIGER AESTHETICS MEDICAL LLC BELLAFILL DERMAL FILLER

Model Number	GBF0508
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025, account reports injection of kenalog 25mg to bumps on oral commissures.Patient was injected with bellafill on (b)(6) 2025 bilaterally in multiple areas.Onset of bumps in off-label areas of oral commissures, and under the right eye ~3 months prior to initial report.It is unknown at this time whether medical intervention is required to resolve the patient's issues.No further information has been provided at this time after multiple attempts.Per the bellafill instructions for use: - 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.B3: date of event - 11/26/2025: date account reports medical intervention.D9: device not available for evaluation.Bellafill syringes are single use devices that are typically discarded after use.Per bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit.".
Event or Problem Description
On (b)(6) 2025, account reports injection of kenalog 25mg to bumps on oral commissures.Patient was injected with bellafill on (b)(6) 2025 bilaterally in multiple areas.Onset of bumps in off-label areas of oral commissures, and under the right eye ~3 months prior to initial report.It is unknown at this time whether medical intervention is required to resolve the patient's issues.No further information has been provided at this time after multiple attempts.

• Brand Name: BELLAFILL DERMAL FILLER
• Common Device Name: BELLAFILL DERMAL FILLER
• Manufacturer (Section D): TIGER AESTHETICS MEDICAL LLC; 5870 pacific center blvd.; san diego CA 92121
• Manufacturer (Section G): TIGER AESTHETICS MEDICAL LLC; 5870 pacific center blvd; san diego CA 92121
• Manufacturer Contact: mauricio torres ; 5870 pacific center blvd; san diego, CA 92121 ; 8585509999
• MDR Report Key: 23900617
• Report Number: 3003707320-2025-00013
• Device Sequence Number: 17425433
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)260305(10)F241077
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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: 03/05/2026
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F241077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female