BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4721843 · Received April 23, 2015

    Report

    Report Number
    3005654090-2015-00014
    Event Type
    Injury
    Date Received
    April 23, 2015
    Report Date
    March 27, 2015
    Manufacturer
    COLBAR LIFESCIENCE, LTD
    Product Code
    LMH
    PMA / PMN Number
    070013
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 2015. THE MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED (B)(4) 2010. 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)(4) 2015 FROM A REPORTER REPORTING FOR A CONSUMER (AGE AND GENDER UNSPECIFIED) FROM THE UNITED STATES IDENTIFIED BY THE REPORTER VIA AN INTERNET SEARCH. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (DOSE, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, FOR AN UNKNOWN INDICATION UNDER THE EYES. AFTER AN UNSPECIFIED DURATION, IN (B)(6) 2009, THE CONSUMER DEVELOPED LUMPS UNDER THE EYES. ON AN UNSPECIFIED DATE, A PLASTIC SURGEON REMOVED THE COLLAGEN FILLER WITH AN UNSPECIFIED SPECIAL TOOL, WHICH WAS DESCRIBED AS YELLOW AND HARD. AFTER AN UNSPECIFIED DURATION, THE USE OF THE DEVICE WAS DISCONTINUED. THE OUTCOME OF THE EVENT WAS UNKNOWN. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAD SUBSEQUENTLY CLOSED. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270666 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention