BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 18499480 · Received January 11, 2024

    Report

    Report Number
    3003707320-2024-00001
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    November 20, 2023
    Report Date
    January 11, 2024
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT STATEMENT OF SEVERE SWELLING AROUND THE EYES REQUIRING VISIT TO URGENT CARE AND MEDICATION. THE PATIENT WAS INJECTED WITH BELLAFILL DERMAL FILLER OFF-LABEL UNDER THE EYES ABOUT 8 (EIGHT) YEARS PRIOR. PATIENT RELAYS THAT SHE HAD STREP WHILE ON VACATION. SHE CAME HOME FROM VACATION AND WAS ABOUT HALF-WAY THROUGH THE ANTIBIOTIC REGIMEN PRESCRIBED FOR STREP WHEN THE SEVERE SWELLING STARTED AROUND HER EYES ABOUT 3 (THREE) WEEKS PRIOR TO REPORTING THE EVENT TO (B)(6) MEDICAL.. SHE STATES THE SWELLING WENT AWAY WITH TREATMENT BUT HAS COME BACK, OFF AND ON. B3: DATE OF EVENT: APPROXIMATE DATE OF 11/20/2023. PATIENT RELAYED THE SEVERE SWELLING AND URGENT CARE VISIT OCCURRED ABOUT 3 (THREE) WEEKS BEFORE SHE REPORTED THE EVENT TO (B)(6) MEDICAL ON (B)(6) 2023. D6A: THE IMPLANT DATE FOR THE BELLAFILL DERMAL FILLER IS UNKNOWN, BUT WAS APPROXIMATELY 8 (EIGHT) YEARS PRIOR, PER PATIENT. BELLAFILL INJECTOR/PROVIDER: DR. (B)(6). PATIENT HAS DECLINED TO RETURN TO THE INJECTOR FOR FOLLOW UP AS SHE NO LONGER LIVES IN (B)(6). SHE RELAYS THAT SHE IS LOOKING FOR ANOTHER PROVIDER IN HER CURRENT STATE OF (B)(6) AND WILL NOTIFY (B)(6) MEDICAL ONCE SHE IS SEEING HER NEW PROVIDER. MANUFACTURING RECORDS FROM LOT: F151021 WERE REVIEWED WITH NO ISSUES NOTED. BELLAFILL DERMAL FILLER 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. BELLAFILL SYRINGES ARE SINGLE USE DEVICES AND ARE TYPICALLY DISCARDED AFTER USE. PER THE BELLAFILL IFU: "THE SYRINGE AND ANY UNUSED MATERIAL SHOULD BE DISCARDED AFTER A SINGLE TREATMENT VISIT."

    Description of Event or Problem · 0

    PATIENT STATEMENT OF SEVERE SWELLING AROUND THE EYES REQUIRING VISIT TO URGENT CARE AND MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101254 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F151021

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention| H