BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4693847 · Received April 15, 2015

    Report

    Report Number
    3005654090-2015-00011
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    October 18, 2010
    Manufacturer
    COLBAR LIFESCIENCE, LTD
    Product Code
    LMH
    PMA / PMN Number
    070013
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(6) 2015. THIS IS AN INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 3005654090-2015-00011. THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IN THIS CASE IS 3005654090-2015-00010. 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 PHYSICIAN REPORTING FOR A (B)(6) FEMALE CONSUMER FROM GERMANY. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2007, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (LOT NUMBER , DOSE AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY FOR AN UNSPECIFIED TREATMENT OF THE UPPER LIP. AFTER AN UNSPECIFIED DURATION, SHE DEVELOPED A NODE WITH REDNESS, INFLAMMATION AND PAIN. ON AN UNSPECIFIED DATE IN (B)(6) 2007, SHE WAS REINJECTED WITH THE DEVICE FOR RETREATMENT IN ORDER TO COMPENSATE THE NODE BUT THE CONDITION DID NOT CHANGE. AFTER AN UNSPECIFIED DURATION THE DEVICE WAS DISCONTINUED. THE EVENTS DID NOT RESOLVE. ALL MARKET DISTRIBUTION OF THE DEVICE HAS 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 (B)(6) 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
    250963 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other