BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23430846 · Received October 30, 2025

    Report

    Report Number
    3003707320-2025-00009
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 30, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, PATIENT REPORTS LUMPS AND DISFIGUREMENT REQUIRING MEDICAL INTERVENTION AFTER OFF-LABEL INJECTION IN THE TEMPLES ON (B)(6) 2020. IT IS UNKNOWN AT THIS TIME IF ANY MEDICAL INTERVENTION HAS BEEN PROVIDED. 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 PATIENT, THE PATIENT'S CURRENT PROVIDER BELIEVES THAT SURGERY MAY BE BEST TO ADDRESS THE PATIENT'S CURRENT ISSUES. ATTEMPTS TO REACH THE PATIENT'S CURRENT PROVIDER TO OBTAIN ADDITIONAL INFORMATION AND TO CONFIRM WHETHER MEDICAL INTERVENTION HAS BEEN DONE, WITH NO ADDITIONAL INFORMATION AT THIS TIME. A2:. AGE AT TIME OF EVENT: PATIENT STATES THAT THEY ARE IN THEIR 50'S. B3: DATE OF EVENT - 09/30/2025: DATE PATIENT INDICATED DISFIGUREMENT REQIURING 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." BELLAFILL INJECTOR: (B)(6). CURRENT PROVIDER: (B)(6).

    Description of Event or Problem · 0

    ON (B)(6) 2025, PATIENT REPORTS LUMPS AND DISFIGUREMENT REQUIRING MEDICAL INTERVENTION AFTER OFF-LABEL INJECTION IN THE TEMPLES ON (B)(6) 2020. IT IS UNKNOWN AT THIS TIME IF ANY MEDICAL INTERVENTION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370084 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F191096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention