BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4705239 · Received April 20, 2015

    Report

    Report Number
    3005654090-2015-00016
    Event Type
    Injury
    Date Received
    April 20, 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 14-MAY-2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 20-APR-2015. 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

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 27-MAR-2015 FROM A REPORTER REPORTING ON A CONSUMER (AGE AND GENDER UNSPECIFIED) FROM THE UNITED STATES. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, FOR AN UNKNOWN INDICATION UNDER BOTH EYES. AFTER AN UNSPECIFIED DURATION, THE CONSUMER HAD TWO LARGE LUMPS UNDER HER RIGHT EYE. THE CONSUMER REPORTED THAT NO DOCTOR WANTED TO REMOVE THE LUMPS BECAUSE OF RISK OF A LARGE SCAR. AFTER AN UNSPECIFIED DURATION, THE USE OF THE DEVICE WAS DISCONTINUED. THE OUTCOME OF THE EVENT WAS UNKNOWN. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 27-MAR-2015 FROM A REPORTER REPORTING ON A CONSUMER (AGE AND GENDER UNSPECIFIED) FROM THE UNITED STATES. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, FOR AN UNKNOWN INDICATION UNDER BOTH EYES. AFTER AN UNSPECIFIED DURATION, THE CONSUMER HAD TWO LARGE LUMPS UNDER HER RIGHT EYE. THE CONSUMER REPORTED THAT NO DOCTOR WANTED TO REMOVE THE LUMPS BECAUSE OF RISK OF A LARGE SCAR. AFTER AN UNSPECIFIED DURATION, THE USE OF THE DEVICE WAS DISCONTINUED. THE OUTCOME OF THE EVENT WAS UNKNOWN. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 07-MAY-2015. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAS SUBSEQUENTLY CLOSED. A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT REMAINS SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261731 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other