BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEFILL

    MDR report key: 1277255 · Received December 17, 2008

    Report

    Report Number
    MW5009496
    Event Type
    Injury
    Date Received
    December 17, 2008
    Date of Event
    October 16, 2008
    Report Date
    December 17, 2008
    Manufacturer
    ARTEC MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBJECT UNDERWENT LAPAROSCOPIC SURGERY FOR REMOVAL OF BENIGN LEFT KIDNEY CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTEFILL PMMA DERMAL FILLER LMH ARTEC MEDICAL, INC. 5071137
    2 RADIESSE CALCIUM HYDROXYLAPATITE FILLER LYC BIOFORM MEDICAL 1008232

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization ESTRACE| ZOLOFT