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	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025, bellafill injector reports multiple nodules (onset ~10/07/2025) after off-label (temples, chin, pre-auricular, lateral right forehead) and on-label (nasolabial folds) injection in (b)(6) 2024, (b)(6) 2025 and indicates that medical intervention is required to resolve the nodules.B3: date of event - 10/21/2025: date injector reports nodules and indicates that medical intervention is required to resolve the nodules.D4: three (3) lot numbers were reported, all from bellafill dermal filler model number: gbf0508: - f241060, udi: (b)(4), expiration date: 01/31/2026.- f241084, udi: (b)(4), expiration date: 03/23/2026.- f251006, udi: (b)(4), expiration date: 09/03/2026.D6a: date of implant: (b)(6) 2024.Three (3) estimated dates were reported: (b)(6) 2024, (b)(6) 2025, and (b)(6) 2025.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." h4: manufacture date: of the three (3) reported lots - f241060, 08/09/2024.- f241084, 10/17/2024.- f251006, 03/26/2025.H6: investigation conclusions: - bellafill providers are aware of the bellafill indications for use.- injector was reminded of the linear retrograde threading technique per bellafill ifu and that bolusing was not recommended.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." - "the best cosmetic result for nlfs can be achieved by a standard linear threading technique, moving the needle back and forth beneath the skin being treated and maintaining constant injection pressure while withdrawing the needle (retrograde liner threading)"."the injection pressure is correct if the implant flows slowly and evenly, without great exertion.This technique forms a support structure beneath the skin to prevent further wrinkling.".
Event or Problem Description
On (b)(6) 2025, bellafill injector reports multiple nodules (onset ~10/07/2025) after off-label (temples, chin, pre-auricular, lateral right forehead) and on-label (nasolabial folds) injection in (b)(6) 2024, (b)(6) 2025 and indicates that medical intervention is required to resolve the nodules.

• 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: 23577802
• Report Number: 3003707320-2025-00011
• Device Sequence Number: 18536329
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)260131(10)F241060
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 01/31/2026
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F241060
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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: 70 YR
• Patient Sex: Female