BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23900617 · Received December 26, 2025

    Report

    Report Number
    3003707320-2025-00013
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 26, 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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, ACCOUNT REPORTS INJECTION OF KENALOG 25MG TO BUMPS ON ORAL COMMISSURES. PATIENT WAS INJECTED WITH BELLAFILL ON (B)(6) 2025 BILATERALLY IN MULTIPLE AREAS. ONSET OF BUMPS IN OFF-LABEL AREAS OF ORAL COMMISSURES, AND UNDER THE RIGHT EYE ~3 MONTHS PRIOR TO INITIAL REPORT. IT IS UNKNOWN AT THIS TIME WHETHER MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUES. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME AFTER MULTIPLE ATTEMPTS. 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 - 11/26/2025: DATE ACCOUNT REPORTS 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."

    Description of Event or Problem · 0

    ON (B)(6) 2025, ACCOUNT REPORTS INJECTION OF KENALOG 25MG TO BUMPS ON ORAL COMMISSURES. PATIENT WAS INJECTED WITH BELLAFILL ON (B)(6) 2025 BILATERALLY IN MULTIPLE AREAS. ONSET OF BUMPS IN OFF-LABEL AREAS OF ORAL COMMISSURES, AND UNDER THE RIGHT EYE ~3 MONTHS PRIOR TO INITIAL REPORT. IT IS UNKNOWN AT THIS TIME WHETHER MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUES. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME AFTER MULTIPLE ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158630 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F241077 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention