BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23139714 · Received September 24, 2025

    Report

    Report Number
    3003707320-2025-00006
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 24, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DOCTOR REPORTS PATIENT WHO RECEIVED OFF-LABEL INJECTIONS OF BELLAFILL BETWEEN 2018 AND 2022 IN THE TEMPLES, CHEEKS, MARIONETTES, AND CHIN, AND SUBSEQUENTLY IN (B)(6) 2023 DEVELOPED MULTIPLE NODULES IN ALL AREAS. THE DOCTOR INDICATES AS OF (B)(6) 2025 THAT MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE NODULES, WHICH PERSIST. DOCTOR STATES THE NODULES "ARE VERY VISIBLE DUE TO THE PATIENT BEING AN AVID EXERCISE INSTRUCTOR AND HAVING ALMOST ZERO BODY FAT." DOCTOR ALSO RELAYS THAT THE PATIENT WAS DIAGNOSED WITH LYMPHOMA IN (B)(6) 2023 (ONE MONTH AFTER ONSET OF THE NODULES). THE LYMPHOMA WAS "CURED" THE FOLLOWING YEAR. THE LOCATION OF THE LYMPHOMA IS UNKNOWN AT THIS TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED AFTER SEVERAL 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. SEVERAL ATTEMPTS TO REACH THE PATIENT'S DOCTORS TO OBTAIN ADDITIONAL INFORMATION AND TO CONFIRM MEDICAL INTERVENTION REQUIRED. NO RESPONSE AT THIS TIME. B3: DATE OF EVENT - 08/25/2025: DATE DOCTOR INDICATED THAT MEDICAL INTERVENTION IS REQUIRED. D4 & H4: TWO BELLAFILL LOTS WERE PROVIDED: F181038, UDI: (B)(4), EXP 09/01/2019, MANUFACTURE DATE: 05/02/2028. F221035, UDI: (B)(4), EXP 10/11/2023, MANUFACTURE DATE: 05/31/2022. 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 - REPORT INDICATING MEDICAL INTERVENTION IS REQUIRED RECEIVED FROM THE DOCTOR ON 08/25/2025.

    Description of Event or Problem · 0

    DOCTOR REPORTS PATIENT WHO RECEIVED OFF-LABEL INJECTIONS OF BELLAFILL BETWEEN 2018 AND 2022 IN THE TEMPLES, CHEEKS, MARIONETTES, AND CHIN, AND SUBSEQUENTLY IN (B)(6) 2023 DEVELOPED MULTIPLE NODULES IN ALL AREAS. THE DOCTOR INDICATES AS OF (B)(6) 2025 THAT MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE NODULES, WHICH PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850306 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F181038

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention