BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE

    MDR report key: 2619041 · Received August 19, 2009

    Report

    Report Number
    3005654090-2009-00002
    Event Type
    Injury
    Date Received
    August 19, 2009
    Report Date
    August 19, 2009
    Manufacturer
    COLBAR LIFESCIENCE LTD.
    Product Code
    LYC
    PMA / PMN Number
    P070013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN THE (B)(4) NEWSPAPER, THE (B)(4), AN ARTICLE APPEARED ON DECEMBER 12, 2008, INDICATING THAT TWO INDIVIDUALS ((B)(6)) DEVELOPED LUMPS AS A RESULT OF EVOLENCE INJECTIONS. THE ARTICLE CLAIMED THAT A LAWSUIT HAD BEEN FILED AND THAT THE INJECTIONS HAVE RESULTED IN PERMANENT OR LONG TERM DAMAGE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THE COMPANY HAS NOT BEEN CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLENCE COLLAGEN DERMAL FILLER LYC COLBAR LIFESCIENCE LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability