BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 23415444 · Received October 29, 2025

    Report

    Report Number
    3003707320-2025-00008
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL LLC
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, BELLAFILL INJECTOR REPORTS A PATIENT THAT WAS INJECTED IN THE NASOLABIAL FOLDS (ON-LABEL) AND PRESENTED WITH TENDERNESS AND SEVERE SWELLING 2 DAYS AFTER INJECTION. ON (B)(6) 2025, IT WAS RELAYED THAT THE SWELLING WAS "DISTORTING" THE PATIENT'S FACE AND THAT THE INJECTOR HAD STARTED MEDICAL INTERVENTION (PREDNISONE). NO FURTHER INFORMATION WAS PROVIDED AFTER MULTIPLE ATTEMPTS. RESULTS ARE UNKNOWN AT THIS TIME. IT IS UNKNOWN WHETHER THE BELLAFILL SKIN TEST WAS ADMINISTERED 28 DAYS BEFORE THE BELLAFILL INJECTION. ALLERGIC REACTION IS SUSPECTED. 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. - A BELLAFILL SKIN TEST MUST BE ADMINISTERED AND EVALUATED PRIOR TO INJECTION OF BELLAFILL. PATIENTS DEMONSTRATING A POSITIVE SKIN TEST, OR 2 EQUIVOCAL SKIN TESTS SHOULD NOT BE CONSIDERED CANDIDATES FOR TREATMENT. MULTIPLE ATTEMPTS TO REACH THE REPORTING MEDICAL PROFESSIONAL TO OBTAIN ADDITIONAL INFORMATION AND TO CONFIRM MEDICAL INTERVENTION, WITH NO ADDITIONAL INFORMATION AT THIS TIME. - (B)(6) 2025: PHONE MESSAGE LEFT FOR PROVIDER. - (B)(6) 2025: EMAIL FROM PROVIDER INDICATING THAT THE SWELLING WAS DISTORTING THE PATIENT'S FACE AND THAT PREDNISONE WAS STARTED. - (B)(6) 2025: EMAIL SENT TO ACCOUNT REQUESTING ADDITIONAL INFORMATION, INCLUDING PATIENT INFO AND STATUS, BELLAFILL LOT NUMBER, AND WHETHER SKIN TEST WAS ADMINISTERED PRIOR TO INJECTIONS. - (B)(6) 2025: NO RESPONSE. PHONE MESSAGE LEFT WITH THE INITIAL REPORTER FOR A RETURN CALL. REMINDER EMAIL ALSO SENT. - (B)(6) 2025: NO RESPONSE. REMINDER EMAIL SENT TO THE ACCOUNT. AT THIS TIME IT IS UNKNOWN WHETHER THIS WAS AN ALLERGIC REACTION OR WHETHER MEDICAL INTERVENTION WAS REQUIRED. B3: DATE OF EVENT - 09/30/2025: DATE FACIAL DISTORTION AND MEDICAL INTERVENTION (PREDNISONE) WAS REPORTED.: 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 BY MANUFACTURER - 09//26/2025: DATE OF INITIAL REPORT OF TENDERNESS AND SEVERE SWELLING.

    Description of Event or Problem · 0

    ON (B)(6) 2025, BELLAFILL INJECTOR REPORTS A PATIENT THAT WAS INJECTED IN THE NASOLABIAL FOLDS (ON-LABEL) AND PRESENTED WITH TENDERNESS AND SEVERE SWELLING 2 DAYS AFTER INJECTION. ON (B)(6) 2025, IT WAS RELAYED THAT THE SWELLING WAS "DISTORTING" THE PATIENT'S FACE AND THAT THE INJECTOR HAD STARTED MEDICAL INTERVENTION (PREDNISONE). NO FURTHER INFORMATION WAS PROVIDED AFTER MULTIPLE ATTEMPTS. RESULTS ARE UNKNOWN AT THIS TIME. IT IS UNKNOWN WHETHER THE BELLAFILL SKIN TEST WAS ADMINISTERED 28 DAYS BEFORE THE BELLAFILL INJECTION. ALLERGIC REACTION IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719170 BELLAFILL DERMAL FILLER BELLAFILL DERMAL FILLER LMH TIGER AESTHETICS MEDICAL LLC GBF0508 (SUSPECTED) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention