BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 5139613 · Received October 9, 2015

    Report

    Report Number
    3005654090-2015-00019
    Event Type
    Injury
    Date Received
    October 9, 2015
    Report Date
    August 25, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON 09-OCT-2015 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (EVOLENCE COLLAGEN FILLER). MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED DECEMBER 20, 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)(6) 2015 FROM A FRIEND REPORTING ON FEMALE FRIEND (AGE UNSPECIFIED) FROM (B)(6). THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING EVOLENCE COLLAGEN FILLER INTRADERMALLY (LOT NUMBER, EXPIRATION DATE, INDICATION AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE REPORTER STATED THAT THE DEVICE LEFT HER FRIEND FACIALLY DEFORMED FOR NINE YEARS. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE EVENT DID NOT RESOLVE. THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671920 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other