BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 6474416 · Received April 7, 2017

    Report

    Report Number
    3003707320-2017-00008
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    March 9, 2017
    Report Date
    April 7, 2017
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ((B)(6)) WAS INJECTED WITH ARTEFILL DERMAL FILLER ON 4 DIFFERENT OCCASIONS BY DR. (B)(6): (B)(6) 2013 WITH 2 SYRINGES IN THE "LOWER LIDS" (OFF-LABEL LOCATION), LOT F121054: EXPIRATION DATE 04/30/2014; MANUFACTURE DATE 12/11/2012. (B)(6) 2013 WITH 4 SYRINGES IN UNKNOWN LOCATION, LOT F121054: EXPIRATION DATE 04/30/2014; MANUFACTURE DATE 12/11/2012. (B)(6) 2013 WITH 1 SYRINGE IN THE "LOWER LIDS" (OFF-LABEL), LOT F131002: EXPIRATION DATE 06/30/2014, MANUFACTURE DATE: 01/15/2013. (B)(6) 2013 WITH A TOTAL OF (B)(4) SYRINGES IN THE "LOWER LIDS", "ML", AND NLF (NLF IS ON-LABEL). LOT F131055: EXPIRATION DATE: 01/31/2015; MANUFACTURE DATE 09/06/2013. SUNEVA CONDUCTED A LOT REVIEW OF ALL LOTS. NO ISSUES WERE FOUND WITH THE LOTS USED IN THE PATIENT'S PROCEDURES. THE LOTS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED WORK INSTRUCTIONS AND MET ACCEPTANCE CRITERIA AT TIME OF PRODUCT RELEASE. THE PATIENT DEVELOPED SUSPECTED GRANULOMA IN THE TEAR TROUGHS (OFF-LABEL LOCATION). THE PATIENT WAS INJECTED IN BOTH ON-LABEL AND OFF-LABEL LOCATIONS: ON-LABEL: NLF (I.E. NASOLABIAL FOLDS); OFF-LABEL: UNDER LIDS (I.E. TEAR TROUGHS) AND "ML". SUNEVA WAS UNABLE TO ASCERTAIN WHAT "ML" STOOD FOR. THE BELLAFILL INJECTOR IS AWARE OF BELLAFILL INDICATIONS FOR USE.

    Description of Event or Problem · 1

    PATIENT ((B)(6)) WAS INJECTED WITH ARTEFILL DERMAL FILLER ON 4 DIFFERENT OCCASIONS BY DR. (B)(6): (B)(6) 2013 WITH 2 SYRINGES IN THE "LOWER LIDS" (OFF-LABEL LOCATION), (B)(6) 2013 WITH 4 SYRINGES IN UNKNOWN LOCATION, (B)(6) 2013 WITH 1 SYRINGE IN THE "LOWER LIDS" (OFF-LABEL), AND (B)(6) 2013 WITH A TOTAL OF 3 SYRINGES IN THE "LOWER LIDS", "ML", AND NLF (NLF IS ON-LABEL). THE PATIENT SUBSEQUENTLY DEVELOPED GRANULOMA IN BOTH TEAR TROUGH AREAS WHICH WAS PRESENTED TO THE DOCTOR IN 2015, AND SUBSEQUENTLY REPORTED TO SUNEVA ON (B)(6) 2017. AFTER MULTIPLE ATTEMPTS TO REACH DR. (B)(6), THE DOCTOR INDICATED VIA EMAIL ON (B)(6) 2017 THAT A BIOPSY WAS NOT DONE TO CONFIRM GRANULOMA AND THAT THE SUSPECTED GRANULOMAS WERE BEING TREATED WITH KENALOG AND 5FU. WHEN ASKED HOW THE PATIENT WAS DOING, THE DOCTOR RESPONDED VIA EMAIL (ALSO ON (B)(6) 2017) THAT THE PATIENT WAS "DISFIGURED FOR LIFE." IT IS UNKNOWN WHY THE DOCTOR BELIEVES THE PATIENT IS "DISFIGURED FOR LIFE." THE DOCTOR WOULD NOT RESPOND TO ADDITIONAL QUESTIONS AND HAS DECLINED ANY FURTHER DISCUSSIONS WITH SUNEVA STATING SHE HAD "NOTHING FURTHER TO ADD". THERE WAS ALSO NO SUBSEQUENT CONTACT FROM THE PATIENT AFTER MULTIPLE ATTEMPTS TO REACH THE PATIENT TO DETERMINE IF SHE WAS STILL SEEING HER INJECTING DOCTOR OR HAD CHOSEN ANOTHER PROVIDER. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253667 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 F121054

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability