BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4693825 · Received April 15, 2015

    Report

    Report Number
    3005654090-2015-00012
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    June 4, 2012
    Manufacturer
    COLBAR LIFESCIENCE, LTD
    Product Code
    LMH
    PMA / PMN Number
    070013
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETROSPECTIVE REVIEW IDENTIFIED THIS COMPLAINT AS REPORTABLE. MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED 20-DEC-2010. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED ON (B)(6) 2012 PROCESSED WITH ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014. THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2007, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (DOSE, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, FOR UNKNOWN INDICATION UNDER BOTH EYES. AFTER AN UNSPECIFIED DURATION, SHE NOTICED PERMANENT LUMPS AND SCARS UNDER HER EYES. ON AN UNSPECIFIED DATE, SHE TRIED HEAT TREATMENT BUT IT ONLY WORKED TEMPORARILY. AFTER AN UNSPECIFIED DURATION, THE USE OF THE DEVICE WAS DISCONTINUED. THE EVENTS DID NOT RESOLVE. THE PRODUCT HAS BEEN DIVESTED OR DISCONTINUED. THERE WAS NO REMEDIATION OR INVESTIGATION FOR THIS COMPLAINT; THEREFORE, THE CASE WAS CLOSED WITH NO FURTHER ACTION. 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 20-DEC-2010. A RETROSPECTIVE REVIEW IDENTIFIED 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
    251557 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other