BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23160200 · Received September 26, 2025

    Report

    Report Number
    3003707320-2025-00007
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    November 9, 2023
    Report Date
    September 26, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 08/28/2025, DOCTOR REPORTS PATIENT WHO RECEIVED OFF-LABEL INJECTIONS OF BELLAFILL IN THE NECK LINES ON (B)(6) 2023 AND DEVELOPED SMALL BUMPS IN THE AREA SOON AFTER. THE BUMPS ARE NOW BETTER, BUT THERE ARE STILL 4 OR 5 VERY SMALL BUMPS THAT REMAIN. THE DOCTOR INDICATES THAT MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE REMAINING BUMPS. DOCTOR STATES THE PATIENT HAS HAD BELLAFILL IN THE FACE MANY TIMES WITHOUT ISSUES. THE PATIENT HAS HAD BOTOX IN THE SAME AREA (NECK LINES) IN THE PAST, PRIOR TO BELLAFILL INJECTIONS. 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. ATTEMPTS TO REACH THE REPORTING DOCTOR TO OBTAIN ADDITIONAL INFORMATION AND TO CONFIRM MEDICAL INTERVENTION REQUIRED HAVE BEEN DONE, WITH NO ADDITIONAL INFORMATION AT THIS TIME. A1 TO A6: NO PATIENT INFO HAS BEEN PROVIDED BY THE PROVIDER AT THIS TIME. B3: DATE OF EVENT 11/09/2023: DATE OF INJECTION AND APPROXIMATE ONSET OF BUMPS ON THE NECK, AS PROVIDED BY THE REPORTING DOCTOR ON (B)(6) 2025: 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 - 08/28/2025: DATE OF DOCTOR REPORT INDICATING MEDICAL INTERVENTION IS REQUIRED.

    Description of Event or Problem · 0

    ON 08/28/2025, DOCTOR REPORTS PATIENT WHO RECEIVED OFF-LABEL INJECTIONS OF BELLAFILL IN THE NECK LINES ON (B)(6) 2023 AND DEVELOPED SMALL BUMPS IN THE AREA SOON AFTER. THE BUMPS ARE NOW BETTER, BUT THERE ARE STILL 4 OR 5 VERY SMALL BUMPS THAT REMAIN. THE DOCTOR INDICATES THAT MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE REMAINING BUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300819 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F231057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention