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	Granuloma (1876)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reports 2 large lumps after off-label bellafill injection in the mouth corners/marionette lines.Per patient (on (b)(6)2025) and current treating doctor (on (b)(6)2025) treatment is required to resolve the lumps.
Additional Manufacturer Narrative
Patient reports 2 large lumps after off-label bellafill injection in the mouth corners/marionette lines.Per patient (on (b)(6)2025) and current treating doctor (on (b)(6)2025) treatment 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.Per the treating physician, they contirm that treatment is required and they are treating the patient's lumps with "ellacor" which "can remove permanent substance".B3: date of event - 01/01/2024: patient indicated lumps were noticed the year prior.D4: per the bellafill injecting office, two (2) bellafill lots from model gbf0508 were used in the patients' procedures: f201067, expiration 04-26-2022, udi (b)(4), f201074, expiration 05-09/2022, udi: (b)(4).D6a: bellafill was implanted on two (2) dates: f201067, implant date: (b)(6) 2021.F201074, implant date: (b)(6) 2021.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." e1, e2, e3: the initial reporter was the patient.G3: date received - report indicating medical intervention is required received from the patient on (b)(6) 2025.Initial report of lumps received on (b)(6) 2025 h4: manufacture date: two (2) lots: f201067: manufacture date: 11/03/2020.F201074: manufacture date: 11/16/2020.Bellafill injector information: dr.(b)(6).Treating physician informaiton: dr.(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: 23102777
• Report Number: 3003707320-2025-00004
• Device Sequence Number: 15777383
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)220426(10)F201067
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: 04/26/2022
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F201067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2020
• 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: 81 YR
• Patient Sex: Female