BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 1635499 · Received March 11, 2010

    Report

    Report Number
    3005654090-2010-00002
    Event Type
    Other
    Date Received
    March 11, 2010
    Date of Event
    December 21, 2009
    Report Date
    February 12, 2010
    Manufacturer
    COLBAR LIFESCIENCE LTD.
    Product Code
    LYC
    PMA / PMN Number
    070013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL, SIGNIFICANT INFO IS RECEIVED. REPORT SENT TO FDA ON (B)(4) 2010.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED (B)(6) 2010, FROM CONSUMER DETAILING THAT SHE WAS INJECTED WITH 2 SYRINGES OF PRODUCT ON (B)(6) 2009, ON SIDES OF MOUTH IN DEEP WRINKLES AND DEVELOPED RED BUMPS THAT BECAME IRRITATED AND SHE HAD TO HAVE THEM DRAINED TWICE BY HER HEALTHCARE PROFESSIONAL. SHE WAS THEN REFERRED TO A PLASTIC SURGEON WHO PERFORMED SURGERY ON (B)(6) 2010, TO REMOVE THE PRODUCT; 7 STITCHES ON ONE SIDE AND 8 STITCHES ON THE OTHER. SHE IS TREATING THE AREAS WITH VITAMIN E AND WAS ADVISED TO MASSAGE THE AREA. SHE NOW HAS SCARS THAT SHE WANTS TO HAVE REMOVED WITH FURTHER SURGERY. SHE ALSO HAD RESTYLANE INJECTED THE SAME DAY ABOVE HER LIP AND AROUND HER MOUTH IN LESSER WRINKLES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other UNSPECIFIED DEPRESSION MEDICATION| TAMOXIFEN (JAN 2008 - PRESENT)| RESTYLANE DERMAL FILLER