BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL DERMAL FILLER

    MDR report key: 3900979 · Received June 16, 2014

    Report

    Report Number
    3003707320-2014-00001
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SUNEVA MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT SENT EMAIL VIA (B)(6) WEBSITE STATING "I HAD ARTEFIL INJECTION LAST YEAR AND WASN'T GIVEN AN ALLERGY TEST. I'M HAVING MAJOR COMPLICATIONS RIGHT NOW, AND HAVE LOST 1/2 OF ONE EAR LOBE DUE TO AN INEXPLICABLE INFECTION AND MOSTLY SILICONE PELLETS ARE COMING OUT OF EAR LOBE. I HAVE PATHOLOGY REPORTS COMING IN WEDNESDAY, (B)(6), AFTER AN EXTENSIVE BIOPSY." AFTER 3 ATTEMPTS TO OBTAIN REQUIRED INFORMATION, PATIENT RESPONDED ON (B)(6) 2014, "HI THERE I'M JUST STARTING TO FEEL BETTER I HAVE STAPH AND I'M HOPING THE CIPRO WORKS THIS IS MY 2ND ROUND OF INEXPLICABLE STAPH AFTER THE INJECTIONS". MULTIPLE ADDITIONAL E-MAIL AND VOICEMAIL ATTEMPTS WERE MADE UP TO TODAY TO OBTAIN REQUIRED INFORMATION WITHOUT FURTHER RESPONSE. IT IS ASSUMED THAT THE PT WAS INJECTED OFF-LABEL WITH NO SKIN TEST PER PT. IT IS ASSUMED THAT THE INJECTIONS WERE OFF-LABEL IN THE EAR LOBE; HOWEVER, NO CONFIRMATION HAS BEEN PROVIDED AND NO RESPONSE AS OF TODAY TO OBTAIN REQUIRED INFORMATION INCLUDING PATIENT STATUS, TREATMENT, PHYSICIAN, OR CONFIRMATION THAT ARTEFIL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353451 ARTEFILL DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH SUNEVA MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability USE OF ARTEFILL AT THIS TIME.| (B)(6) IS UNABLE TO CONFIRM DIAGNOSIS AND| UNK - NO RESPONSE TO REQUEST FOR THIS INFORMATION