BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 24157502 · Received January 22, 2026

    Report

    Report Number
    3003707320-2026-00001
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 22, 2026
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    UDI-DI
    10350224000025
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, PATIENT REPORTS THAT SHE IS RECEIVING TREATMENT (STEROID INJECTIONS) FOR OFF AND ON LUMPS IN THE ORAL COMMISSURES AND PAIN WHERE THE LUMPS ARE IRRITATED BY CONTACT WITH HER TEETH INSIDE HER MOUTH PATIENT WAS INJECTED OFF-LABEL WITH BELLAFILL ON (B)(6) 2023 IN THE ORAL COMMISSURES. ONSET OF LUMPS BEGAN ON (B)(6) 2023. IT IS UNKNOWN AT THIS TIME WHETHER MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUES; HOWEVER, IT IS SUSPECTED DUE TO THE PATIENT'S STATEMENT. INJECTOR STATES THEY WILL SEE THE PATIENT FOR EXAM AND LET US KNOW STATUS. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE INJECTOR 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: 12/23/2025: DATE PATIENT INDICATES THAT MEDICAL INTERVENTION IS REQUIRED TO RESOLVE ISSUES. D6A: IMPLANT DATE: ON (B)(6) 2023. PATIENT WAS INJECTED IN BOTH ON (B)(6) 2023 WITH A TOTAL OF 6 YRINGES IN THE ORAL COMMISSURES. 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." BELLAFILL PROVIDER/INJECTOR: (B)(6).

    Description of Event or Problem · 0

    ON (B)(6) 2025, PATIENT REPORTS THAT SHE IS RECEIVING TREATMENT (STEROID INJECTIONS) FOR OFF AND ON LUMPS IN THE ORAL COMMISSURES AND PAIN WHERE THE LUMPS ARE IRRITATED BY CONTACT WITH HER TEETH INSIDE HER MOUTH PATIENT WAS INJECTED OFF-LABEL WITH BELLAFILL ON (B)(6) 2023 IN THE ORAL COMMISSURES. ONSET OF LUMPS BEGAN ON (B)(6) 2023. IT IS UNKNOWN AT THIS TIME WHETHER MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUES; HOWEVER, IT IS SUSPECTED DUE TO THE PATIENT'S STATEMENT. INJECTOR STATES THEY WILL SEE THE PATIENT FOR EXAM AND LET US KNOW STATUS. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE INJECTOR AFTER MULTIPLE ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218915 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F231053 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention