BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL DERMAL FILLER

    MDR report key: 7261477 · Received February 9, 2018

    Report

    Report Number
    3003707320-2018-00004
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    November 3, 2016
    Report Date
    February 9, 2018
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS INJECTED WITH BELLAFILL OFF-LABEL IN THE TEAR TROUGHS ON (B)(6) 2016. WHAT WAS THOUGHT TO BE A LUMP ("PIGMENTED LUMPY LINE") IN HER TEAR TROUGH WAS DIAGNOSED AS XANTHELASMA ON (B)(6) 2018. THE TREATMENT FOR XANTHELASMA IS EXCISION. THE XANTHELASMA HAS NOT BEEN REMOVED AT THIS TIME. WHILE XANTHELASMA IS NOT HARMFUL, IT DOES REQUIRE REMOVAL TO RESOLVE. AS OF (B)(6) 2018, AN EXCISION HAS NOT BEEN SCHEDULED. PATIENT WAS INJECTED ON (B)(6) 2016 WITH BELLAFILL DERMAL FILLER. THE ACCOUNT PROVIDED TWO LOT NUMBERS: LOT F151114; MODEL GBF0508; EXPIRATION DATE: 02/07/2017; MANUFACTURE DATE: 10/19/2015; UDI: (B)(4). LOT F161006; MODEL GBF0508; EXPIRATION DATE: 05/30/2017; MANUFACTURE DATE: 02/03/2016; UDI: (B)(4). PATIENT WAS ALSO INJECTED ON-LABEL IN ACNE SCARS IN THE CHEEKS AT THE SAME TIME WITH NO ISSUES NOTED. BOTH LOTS HAD EXPIRED AT THE TIME OF THE REPORT; THEREFORE, RETAINED LOT SAMPLES COULD NOT BE REVIEWED. HOWEVER, MANUFACTURING RECORDS WERE REVIEWED FOR BOTH LOTS: BOTH LOTS WERE MANUFACTURED ACCORDING TO APPROVED WORK INSTRUCTIONS AND MET ALL ACCEPTANCE CRITERIA UPON RELEASE.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH BELLAFILL OFF-LABEL IN THE TEAR TROUGHS ON (B)(6) 2016. WHAT WAS THOUGHT TO BE A LUMP ("PIGMENTED LUMPY LINE") IN HER TEAR TROUGH WAS SUBSEQUENTLY DIAGNOSED AS XANTHELASMA ON (B)(6) 2018. THE TREATMENT FOR XANTHELASMA IS EXCISION. THE XANTHELASMA HAS NOT BEEN REMOVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103215 BELLAFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. GBF0508 F151114

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention