BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 7431225 · Received April 13, 2018

    Report

    Report Number
    3003707320-2018-00006
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    May 24, 2017
    Report Date
    April 13, 2018
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAS "TISSUE BREAKDOWN" THAT PRESENTED ABOUT 5 YEARS AFTER OFF- LABEL ARTEFILL INJECTIONS IN THE CHIN AND ABOVE THE UPPER LIP, RESULTING IN AN OPENING IN THE SKIN ON THE CHIN AREA REQUIRING SUTURES. THIS INITIALLY PRESENTED (B)(6) 2017 AND WAS THOUGHT TO BE THE RESULT OF A CASE OF IMPETIGO ON THE LOWER FACE UNRELATED TO THE ARTEFILL INJECTIONS. THE SUSPECTED IMPETIGO WAS TREATED WITH LED TREATMENTS AND ANTIBIOTICS AND APPEARED TO BE GETTING BETTER. HOWEVER ON (B)(6) 2018 THE PHYSICIAN RELAYED THAT TESTING HAD RULED OUT IMPETIGO. THE CAUSE OF THE TISSUE BREAKDOWN IS UNKNOWN AT THIS TIME; HOWEVER THE PHYSICIAN RELAYED (ALSO ON (B)(6) 2018) THAT A BIOPSY INDICATED THAT THE PATIENT HAD CONFIRMED GRANULOMA IN THE AREA OF THE INJECTIONS WHICH IS SUSPECTED TO BE ARTEFILL-RELATED. THE PATIENT WAS INJECTED WITH LOT F121006 ON TWO OCCASIONS: 6 SYRINGES INJECTED ON (B)(6) 2012 AND 3 ADDITIONAL SYRINGES INJECTED ON (B)(6) 2012. MANUFACTURING RECORDS FOR THE LOT USED IN THE PROCEDURE (F121006) WERE REVIEWED AND THE LOT MET ALL ACCEPTANCE CRITERIA UPON RELEASE. THE LOT EXPIRED IN (B)(6) 2013, THEREFORE RETAINED LOT SAMPLES WERE NOT AVAILABLE FOR REVIEW. AT THE TIME OF INJECTIONS IN 2012, ARTEFILL WAS INDICATED FOR THE CORRECTION OF NASOLABIAL FOLDS. THE PRODUCT HAS SINCE BEEN REBRANDED AS "BELLAFILL" AND IS NOW ALSO INDICATED FOR MODERATE TO SEVERE, ATROPHIC, DISTENSIBLE FACIAL ACNE SCARS ON THE CHEEK IN PATIENTS OVER THE AGE OF 21 YEARS.

    Description of Event or Problem · 1

    PATIENT HAS "TISSUE BREAKDOWN" THAT PRESENTED ABOUT 5 YEARS AFTER OFF- LABEL ARTEFILL INJECTIONS IN THE CHIN AND ABOVE THE UPPER LIP, RESULTING IN AN OPENING IN THE SKIN ON THE CHIN AREA REQUIRING SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270847 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 F121006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention