BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 7680151 · Received July 11, 2018

    Report

    Report Number
    3003707320-2018-00012
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    July 8, 2008
    Report Date
    July 10, 2018
    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 · 1

    SUNEVA MEDICAL IS FILING THIS EMDR FROM A CONSERVATIVE STANDPOINT BASED ON A MEDWATCH FILED RECENTLY BY THE PATIENT (MEDWATCH MW5077470). ON 06/11/2018, SUNEVA COMPLAINT DEPARTMENT RECEIVED MEDWATCH MW5077470. PATIENT INDICATES "SERIOUS INJURY" UNDER EVENT REPORT TYPE AND "DISABILITY/PERMANENT DAMAGE" UNDER EVENT OUTCOME, IMPLYING THAT ARTEFILL INJECTED AROUND HER MOUTH HAS PERMANENTLY CHANGED THE WAY HER LIPS MOVE. MORE DETAILS CAN BE FOUND ON MW5077470. THE PATIENT HAD PREVIOUSLY REPORTED LUMPS/BUMPS AROUND THE MOUTH TO SUNEVA MEDICAL ON (B)(6) 2018. THE PATIENT ALSO RELAYED SOME STIFFNESS AROUND THE MOUTH; HOWEVER THERE WAS NO INDICATION THAT THE STIFFNESS WAS DISABILITY/PERMANENT DAMAGE. INFORMATION PROVIDED BY THE INJECTOR (DR. (B)(6)) INDICATED THEY LAST SAW THE PATIENT IN 2009 AFTER HER INJECTIONS. PATIENT WOULD NOT PROVIDE INFORMATION RELATED TO ANY CURRENT DOCTOR, BUT WOULD NOT GO BACK TO SEE HER INJECTOR. THE PATIENT INDICATED SHE SAW HER INJECTOR IN 2014. DR. (B)(6) OFFICE DID NOT INDICATE ANY PATIENT VISIT AFTER 2009. IT WAS RELAYED TO THE PATIENT THAT, IF SHE IS NOT SEEING DR. (B)(6), SHE CHOOSE ANOTHER PHYSICIAN TO DETERMINE/DIAGNOSE HER CURRENT ISSUES. THE INJECTOR'S OFFICE PROVIDED TWO LOT NUMBERS USED IN THE PATIENT'S PROCEDURE ON (B)(6) 2008: LOT F081006, MODEL AF0508, EXPIRATION DATE: 01/31/2009; MANUFACTURE DATE: 02/27/2008. LOT F081030, MODEL AF0504, EXPIRATION DATE: 12/31/2008; MANUFACTURE DATE: 04/11/2008. THE MANUFACTURING RECORDS FOR BOTH LOTS WERE REVIEWED WITH NO ISSUES NOTED. BOTH LOTS HAVE SINCE EXPIRED; THEREFORE RETAINED LOT SAMPLES WERE UNAVAILABLE FOR REVIEW. PER HER INJECTOR (DR. (B)(6) OFFICE) THE PATIENT WAS INJECTED IN BOTH ON-LABEL (NASOLABIAL FOLDS) AND OFF-LABEL (MARIONETTE LINES) LOCATIONS. AT THE TIME OF THE INJECTION, ARTEFILL (NOW KNOWN AS BELLAFILL) WAS INDICATED FOR THE NASOLABIAL FOLDS. INJECTOR INFORMATION: (B)(6).

    Description of Event or Problem · 1

    PATIENT, VIA MEDWATCH MW5077470, INDICATES "SERIOUS INJURY," IMPLYING THAT ARTEFILL INJECTED AROUND HER MOUTH HAS PERMANENTLY CHANGED THE WAY HER LIPS MOVE. PATIENT WAS INJECTED IN BOTH ON-LABEL (NASOLABIAL FOLDS AKA SMILE LINES) AND OFF-LABEL (MARIONETTE LINES) AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518588 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. AF0508 F081006

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability