BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE

    MDR report key: 2619040 · Received August 10, 2009

    Report

    Report Number
    3005654090-2009-00001
    Event Type
    Injury
    Date Received
    August 10, 2009
    Date of Event
    June 26, 2009
    Report Date
    August 6, 2009
    Manufacturer
    COLBAR LIFESCIENCE LTD.
    Product Code
    LMH
    PMA / PMN Number
    P070013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # 2587 AND EXPIRATION DATE: 04/01/2010. THE KOL CONCLUDED THE CASE AS A HERPES SIMPLEX INFECTION AT THE SITE OF DERMAL FILLER INJECTIONS, WHICH WAS TREATED WITH LOCAL STEROID. THE (B)(6) DOES NOT THINK THAT THE PRODUCT IS RELATED TO THE FILLER ITSELF BECAUSE THE LESION APPEARED 48 HOURS AFTER INJECTION ADN WAS AGGRAVATED BY THE USAGE OF LOCAL STEROIDS. THE INITIAL REPORT ON (B)(6), 2009 INCLUDED ONLY EDEMA, HEMATOMA AND REDNESS. THE COMPANY WAS NOT INFORMED UNTIL (B)(6), 2009 OF THE PRESENCE OF A SCAR, AT WHICH POINT THIS ADVERSE EVENT WAS DETERMINED TO BE REPORTABLE.

    Description of Event or Problem · 1

    THE PT WAS INJECTED WITH EVOLENCE TO THE GLABELLA AREA. A 48 HOURS LATER, SHE DEVELOPED EDEMA, HEMATOMA AND REDNESS AT THE GLABELLA AREA. THE TREATING PHYSICIAN PRESCRIBED LOCAL STEROID OINTMENT LOCALLY AND AUGMENTIN PO. DUE TO UNRESPONSIVENESS TO THE TREATMENT, THE PT WAS REFERRED TO THE (B)(6) (FOUR DAYS AFTER THE INITIAL TREATMENT WITH EVOLENCE), WHO DIAGNOSED HERPES SIMPLEX ERUPTION AGGRAVATED BY THE USE OF LOCAL STEROIDS. (B)(6) RECOMMENDED VALTREX (ANTIVIRAL TREATMENT) 1G/DAY FOR 7 DAYS AND CEFORAL 2G/DAY AND FUCIDIN OINTMENT LOCALLY. ABOUT TWO WEEKS AFTER INJECTION OF EVOLENCE THE PT WAS PRESENTED WITH A SCAR (2X1 CM) AT THE GLABELLA AREA. THE COMPANY WAS NOTIFIED OF THE SCAR ON (B)(6), 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLENCE COLLAGEN DERMAL FILLER LMH COLBAR LIFESCIENCE LTD. 2869

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability