BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 1586161 · Received January 22, 2010

    Report

    Report Number
    3005654090-2010-00001
    Event Type
    Other
    Date Received
    January 22, 2010
    Date of Event
    January 1, 2007
    Report Date
    December 22, 2009
    Manufacturer
    COLBAR LIFESCIENCE LTD.
    Product Code
    LMH
    PMA / PMN Number
    070013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLIANT RECEIVED ON (B)(6) 2009 FROM A LAWYER DETAILING THAT A (B)(6) OLD FEMALE WAS INJECTED IN LIPS AND BORDER OF LIPS WITH EVOLENCE IN OR ABOUT (B)(6) 2007. SINCE BEING INJECTED WITH THE PRODUCT, PLAINTIFF HAS AND CONTINUES TO HAVE VISIBLE NODULES IN HER LIPS AS A CONSEQUENCE OF WHICH HER LIPS HAVE BEEN DISFIGURED. SHE HAD AND CONTINUES TO SUFFER NUMEROUS INFECTIONS IN HER LIPS. SHE HAS AND CONTINUES TO SUFFER ABSCESSES IN HER LIPS DURING WHICH YELLOWISH SUBSTANCE HAS LEAKED OUT. NO FURTHER CLINICAL INFORMATION IS AVAILABLE. THIS CLOSED OUT THIS REPORT UNLESS ADDITIONAL, SIGNIFICANT INFORMATION IS RECEIVED. REPORT SENT TO FDA ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other