BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4721841 · Received April 23, 2015

    Report

    Report Number
    3005654090-2015-00002
    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 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 ON 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 IN 2009, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE FOR AN UNKNOWN INDICATION UNDER BOTH EYES. AFTER AN UNSPECIFIED DURATION, THE CONSUMER DEVELOPED BUMPS UNDER EACH EYE. ON UNSPECIFIED DATES, THE CONSUMER WAS TREATED WITH SALINE INJECTIONS, RESTYLANE (NON-ANIMAL STABILIZED HYALURONIC ACID) AND CORTISONE (CORTICOSTEROID) INJECTIONS (DOSE AND FREQUENCY UNSPECIFIED FOR ALL) TO MINIMIZE THE BUMPS. ON AN UNSPECIFIED DATE, THE BUMPS WERE SURGICALLY REMOVED BY AN OCULOFACIAL PLASTIC SURGEON AND THE EVENT RESOLVED. THE SURGERY LEFT A SCAR UNDER EACH EYE. THE ACTION TAKEN WITH THE DEVICE 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
    270186 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention