BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 24460519 · Received February 26, 2026

    Report

    Report Number
    3003707320-2026-00002
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 26, 2026
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026, INJECTOR REPORTED MEDICAL INTERVENTION FOR A PATIENT WITH NODULES THAT APPEARED RECENTLY. PATIENT HAD BEEN INJECTED IN NASOBIAL FOLDS ~7 YEARS PRIOR. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. B3: DATE OF EVENT - 01/26/2026: DATE DOCTOR REPORTED MEDICAL INTERVENTION. B7: PATIENT HAD HYALURONIC ACID FILLERS IN THE SAME AREAS. PRODUCT BRAND IS UNKNOWN. D6A: IMPLANT DATE - BLANK. DATE OF IMPLANT IS UNKNOWN. WAS ~7 YEARS AGO. G3: DATE RECEIVED BY MANUFACTURER: 01/26/2026, DATE DOCTOR REPORTED 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."

    Description of Event or Problem · 0

    ON (B)(6) 2026, INJECTOR REPORTED MEDICAL INTERVENTION FOR A PATIENT WITH NODULES THAT APPEARED RECENTLY. PATIENT HAD BEEN INJECTED IN NASOBIAL FOLDS ~7 YEARS PRIOR. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION IS REQUIRED TO RESOLVE THE PATIENT'S ISSUE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257115 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 F171062

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention HYALURONIC ACID FILLER.