BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 18062160 · Received November 2, 2023

    Report

    Report Number
    3003707320-2023-00013
    Event Type
    Injury
    Date Received
    November 2, 2023
    Report Date
    November 2, 2023
    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 INDICATES DISFIGUREMENT REQUIRING SURGERY TO RESOLVE AFTER OFF-LABEL BELLAFILL DERMAL FILLER INJECTIONS UNDER THE EYES. B3 - DATE OF EVENT: UNKNOWN. PATIENT INDICATED DISFIGUREMENT REQUIRING SURGERY TO RESOLVE ON (B)(6) 2023. D6B - EXPLANT DATE: DATE OF SURGERY, IF ANY, IS UNKNOWN. BELLAFILL INJECTOR/PROVIDER: DR.(B)(6). - DISCUSSIONS WITH THE INJECTING OFFICE INDICATE THEY WERE NOT AWARE OF THE PATIENT'S ISSUES, BUT STATE THE PATIENT IS WELCOME TO COME BACK TO THEM FOR A FOLLOW UP. THIS WAS RELAYED TO THE PATIENT. - PATIENT HAS DECLINED TO RETURN TO THE INJECTOR FOR FOLLOW UP AS SHE NO LONGER LIVES IN ATLANTA. SHE HAS NOT RESPONDED TO QUESTION ON WHETHER SHE IS SEEING ANOTHER PROVIDER. MANUFACTURING RECORDS FROM LOT F151009 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 INDICATES DISFIGUREMENT REQUIRING SURGERY TO RESOLVE AFTER OFF-LABEL BELLAFILL DERMAL FILLER INJECTIONS UNDER THE EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042994 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F151009

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention