MAUDE Adverse Event Report: TIGER AESTHETICS MEDICAL LLC BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number	GBF058
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 03/06/2026, injector reported severe allergic reaction after off-label injection of bellafill dermal filler in the temple area.Further information was provided on 04/04/2026 that the allergy had settled after medical intervention.
Additional Manufacturer Narrative
On 03/06/2026, injector reported severe allergic reaction after off-label injection of bellafill dermal filler in the temple area.Per bellafill inidications for use "bellafiil is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek".Doctor states that patient was also injected in the same area with other dermal filler, teosyal.The maker of this other dermal filler will be contacted to be notified of this event.Further information was provided on 04/04/2026 that the allergy had settled after medical intervention.B3: date of event - 04/04/2026: date doctor reported medical intervention.B7: patient had teosyal dermal filler in the same areas.G3: date received by manufacturer: 04/04/2026, date doctor reported medical intervention d9: device not available for evaluation.Bellafill syrenges 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." bellafill indications 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.

• Brand Name: BELLAFILL DERMAL FILLER
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): TIGER AESTHETICS MEDICAL LLC; 5870 pacific center blvd.; san diego CA 92121
• Manufacturer (Section G): TIGER AESTHETICS MEDICAL LLC; 5870 pacifica center blvd; san diego CA 92121
• Manufacturer Contact: mauricio torres ; 5870 pacific center blvd; san diego, CA 92121
• MDR Report Key: 25070961
• Report Number: 3003707320-2026-00003
• Device Sequence Number: 16069990
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)270512(10)F251074
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/24/2026

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 Model Number: GBF058
• Device Catalogue Number: GBF0508
• Device Lot Number: F251074
• 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: 04/04/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TEOSYAL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Unknown