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	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, doctor's office confirms lumps after off-label injection in the temples and in the cheeks (near the marionettes) in (b)(6) 2022 and confirms medical intervention.It is unknown at this time if medical intervention is required to resolve the lumps.
Additional Manufacturer Narrative
On (b)(6) 2025, doctor's office confirms lumps after off-label injection in the temples and in the cheeks (near the marionettes) in may 2022 and confirms medical intervention.It is unknown at this time if medical intervention is required to resolve the lumps.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 - (b)(6) 2025: date doctor's office confirms lumps and 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." g3: date received by manufacturer - 03/06/2023.Initial patient report of lumps in the temples and cheeks.No response from patient after multiple attempts to obtain additional information.On (b)(6) 2025, patient provided name of injector (dr.(b)(6)) and gave permission to contact them.On (b)(6) 2025, after 4 attempts was able to speak with the doctor's office to obtain some additional information including bellafill lot number and confirmation of medical intervention.No further information has been provided.Bellafill injector and treating doctor: (b)(6).

• 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: 23478024
• Report Number: 3003707320-2025-00010
• Device Sequence Number: 18749722
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)230907(10)F221020
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: 09/07/2023
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F221020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2022
• 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 Sex: Female