BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 18195946 · Received November 22, 2023

    Report

    Report Number
    3003707320-2023-00014
    Event Type
    Injury
    Date Received
    November 22, 2023
    Report Date
    November 22, 2023
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WAS INJECTED OFF-LABEL IN THE CHIN WITH ARTEFILL DERMAL FILLER. PATIENT FILED MEDWATCH MW5146519, RECEIVED BY SUNEVA 10/24/23, THAT RELAYS GRANULOMA, ATROPHY, AND DISFIGUREMENT AND INDICATED THAT MEDICAL INTERVENTION/SURGERY WAS REQUIRED. B3 - DATE OF EVENT: UNKNOWN. D4- PER THE INJECTOR/PROVIDER'S OFFICE, THE PATIENT WAS INJECTED WITH ARTEFILL DERMAL FILLER, MODEL AF0508, ON 2 OCCASIONS: ON (B)(6) 2011 WITH ARTEFILL LOT F111039, EXPIRATION DATE: 12/31/2012. ON (B)(6) 2013 WITH ARTEFILL LOT F121034, EXPIRATION DATE: 11/30/2013. D6A - IMPLANT DATE: TWO DATES, (B)(6) 2011 AND (B)(6) 2013. D6B - EXPLANT DATE: PATIENT INDICATES THERE WAS AN ATTEMPT AT EXCISION. DATE(S) ARE UNKNOWN. ARTEFILL DERMAL FILLERL INJECTOR/PROVIDER: (B)(6). OTHER SUBSEQUENT PROVIDER: (B)(6). MANUFACTURING RECORDS FOR BOTH REPORTED LOTS WERE REVIEWED WITH NO ISSUES NOTED. ARTEFILL (NOW 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. ARTEFILL (NOW 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 WAS INJECTED OFF-LABEL IN THE CHIN WITH ARTEFILL DERMAL FILLER. PATIENT FILED MEDWATCH MW5146519, RECEIVED BY SUNEVA 10/24/23, THAT RELAYS GRANULOMA, ATROPHY, AND DISFIGUREMENT AND INDICATED THAT MEDICAL INTERVENTION/SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042171 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R| S