BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4693305 · Received April 15, 2015

    Report

    Report Number
    3005654090-2015-00009
    Event Type
    Injury
    Date Received
    April 15, 2015
    Date of Event
    February 1, 2008
    Report Date
    August 12, 2010
    Manufacturer
    COLBAR LIFESCIENCE, LTD
    Product Code
    LMH
    PMA / PMN Number
    070013
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2015. MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED 20-DEC-2010. A RETROSPECTIVE REVIEW IDENTIFIED THIS COMPLAINT AS REPORTABLE ON (B)(6) 2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM A (B)(6) YEAR-OLD FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED KINGDOM. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. IN (B)(6) 2008, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (DOSE, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, BY A DOCTOR AS COLLAGEN FILLER ON THE OUTSIDE CORNERS OF HER EYES AND UNDERNEATH THE PERI-ORBITAL AREA. IMMEDIATELY, SHE DEVELOPED UNEVEN BUMPS, LUMPS AND WHITE LUMPS UNDER THE SKIN OF HER FACE AND IN THE PERI-ORBITAL AREA. OVER THE NEXT FEW DAYS, SHE NOTICED THE EVENTS DID NOT SUBSIDE AND APPEARED WORSE AS THE BUMPS BECAME MORE PROMINENT AFTER THE INITIAL SWELLING AT THE INJECTION SITE WENT DOWN. AFTER TWELVE MONTHS, THE BUMPS DID NOT DISAPPEAR AND SHE DESCRIBES HER FACE AS DISFIGURED. AFTER AN UNSPECIFIED DURATION, THE USE OF DEVICE WAS DISCONTINUED. THE EVENTS DID NOT RESOLVE. ALL MARKET DISTRIBUTION OF THE DEVICE HAD BEEN DISCONTINUED. COMPLAINTS WILL CONTINUE TO BE MONITORED. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED 20-DEC-2010. A RETROSPECTIVE REVIEW IDENTIFIED THIS COMPLAINT AS REPORTABLE ON (B)(6) 2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251759 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other