BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23577802 · Received November 17, 2025

    Report

    Report Number
    3003707320-2025-00011
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 17, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    UDI-DI
    10350224000025
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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..."

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236105 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F241060 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention