BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 25070961 · Received May 4, 2026

    Report

    Report Number
    3003707320-2026-00003
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 24, 2026
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    UDI-DI
    10350224000025
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 03/06/2026, INJECTOR REPORTED SEVERE ALLERGIC REACTION AFTER OFF-LABEL INJECTION OF BELLAFILL DERMAL FILLER IN THE TEMPLE AREA. PER BELLAFILL INIDICATIONS FOR USE "BELLAFIIL IS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS AND MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK". DOCTOR STATES THAT PATIENT WAS ALSO INJECTED IN THE SAME AREA WITH OTHER DERMAL FILLER, TEOSYAL. THE MAKER OF THIS OTHER DERMAL FILLER WILL BE CONTACTED TO BE NOTIFIED OF THIS EVENT. FURTHER INFORMATION WAS PROVIDED ON 04/04/2026 THAT THE ALLERGY HAD SETTLED AFTER MEDICAL INTERVENTION. B3: DATE OF EVENT - 04/04/2026: DATE DOCTOR REPORTED MEDICAL INTERVENTION. B7: PATIENT HAD TEOSYAL DERMAL FILLER IN THE SAME AREAS. G3: DATE RECEIVED BY MANUFACTURER: 04/04/2026, DATE DOCTOR REPORTED MEDICAL INTERVENTION D9: DEVICE NOT AVAILABLE FOR EVALUATION. BELLAFILL SYRENGES 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 INDICATIONS 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.

    Description of Event or Problem · 0

    ON 03/06/2026, INJECTOR REPORTED SEVERE ALLERGIC REACTION AFTER OFF-LABEL INJECTION OF BELLAFILL DERMAL FILLER IN THE TEMPLE AREA. FURTHER INFORMATION WAS PROVIDED ON 04/04/2026 THAT THE ALLERGY HAD SETTLED AFTER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221350 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH TIGER AESTHETICS MEDICAL LLC GBF058 F251074 10350224000025

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown Required Intervention TEOSYAL.