BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4692423 · Received April 15, 2015

    Report

    Report Number
    3005654090-2015-00008
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    January 5, 2010
    Manufacturer
    COLBAR LIFESCIENCE, LTD
    Product Code
    LMH
    PMA / PMN Number
    070013
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED (B)(4) 2010. A RETROSPECTIVE REVIEW IDENTIFIED THIS COMPLAINT AS REPORTABLE ON (B)(4) 2015. 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) 2010 FROM A PHYSICIAN REPORTING FOR A CONSUMER (AGE AND GENDER UNSPECIFIED) FROM (B)(6). MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (LOT NUMBER 3235, DOSE AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE, FOR AN UNKNOWN INDICATION. AFTER AN UNSPECIFIED DURATION, THE CONSUMER DEVELOPED AN INFECTION WHEREIN THE UNSPECIFIED AREA BECAME RED, PAINFUL, TENDER, SORE, WARM, UNEVEN AND PEELING. ON AN UNSPECIFIED DATE, THE CONSUMER CONSULTED A PHYSICIAN AND WAS TREATED WITH HIGH DOSE OF ORAL MACROLIDE ANTIBIOTICS FOR TWO WEEKS. AFTER AN UNSPECIFIED DURATION, THE INFECTION WAS RESOLVING BUT THE AREA BECAME LUMPY AND HARD. AFTER AN UNSPECIFIED DURATION, THE USE OF THE DEVICE WAS DISCONTINUED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED (B)(4) 2010. A RETROSPECTIVE REVIEW IDENTIFIED THIS COMPLAINT AS REPORTABLE ON (B)(4) 2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249805 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS 3235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention