BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23478024 · Received November 5, 2025

    Report

    Report Number
    3003707320-2025-00010
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 5, 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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, DOCTOR'S OFFICE CONFIRMS LUMPS AFTER OFF-LABEL INJECTION IN THE TEMPLES AND IN THE CHEEKS (NEAR THE MARIONETTES) IN MAY 2022 AND CONFIRMS MEDICAL INTERVENTION. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION 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. B3: DATE OF EVENT - (B)(6) 2025: DATE DOCTOR'S OFFICE CONFIRMS LUMPS AND 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." G3: DATE RECEIVED BY MANUFACTURER - 03/06/2023. INITIAL PATIENT REPORT OF LUMPS IN THE TEMPLES AND CHEEKS. NO RESPONSE FROM PATIENT AFTER MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. ON (B)(6) 2025, PATIENT PROVIDED NAME OF INJECTOR (DR. (B)(6)) AND GAVE PERMISSION TO CONTACT THEM. ON (B)(6) 2025, AFTER 4 ATTEMPTS WAS ABLE TO SPEAK WITH THE DOCTOR'S OFFICE TO OBTAIN SOME ADDITIONAL INFORMATION INCLUDING BELLAFILL LOT NUMBER AND CONFIRMATION OF MEDICAL INTERVENTION. NO FURTHER INFORMATION HAS BEEN PROVIDED. BELLAFILL INJECTOR AND TREATING DOCTOR: (B)(6).

    Description of Event or Problem · 0

    ON (B)(6) 2025, DOCTOR'S OFFICE CONFIRMS LUMPS AFTER OFF-LABEL INJECTION IN THE TEMPLES AND IN THE CHEEKS (NEAR THE MARIONETTES) IN (B)(6) 2022 AND CONFIRMS MEDICAL INTERVENTION. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE LUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681880 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F221020 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention