BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 5268415 · Received December 4, 2015

    Report

    Report Number
    3005654090-2015-00020
    Event Type
    Injury
    Date Received
    December 4, 2015
    Report Date
    December 12, 2012
    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 04-DEC-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. UNABLE TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AS THE CONTACT INFORMATION OF THE REPORTER IS NOT AVAILABLE. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 12-DEC-2012 FROM A (B)(6) YEAR-OLD FEMALE CONSUMER REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2008, EVOLENCE COLLAGEN FILLER (LOT NUMBER, EXPIRATION DATE, DOSE AND FREQUENCY UNSPECIFIED) WAS ADMINISTERED INTRADERMALLY BY A DOCTOR INTO THE MOUTH OF THE CONSUMER. AFTER AN UNSPECIFIED DURATION, THE CONSUMER DEVELOPED GRANULES AND A LARGE BUMP THAT RESULTED IN A DEFORMED AND DISFIGURED APPEARANCE. SHE DESCRIBED THE BUMP AS A HARD BALL OF COLLAGEN. ON AN UNSPECIFIED DATE, A DOCTOR WAS CONSULTED AND THE EVENT WAS TREATED WITH MULTIPLE LASER PROCEDURES. THE CONSUMER TRIED UNSPECIFIED PROCEDURES TO BREAK UP THE BUMP. 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
    799287 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other