BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23102777 · Received September 19, 2025

    Report

    Report Number
    3003707320-2025-00004
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    January 1, 2024
    Report Date
    September 19, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196458 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F201067 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention