BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLENCE COLLAGEN FILLER

    MDR report key: 4725554 · Received April 24, 2015

    Report

    Report Number
    3005654090-2015-00013
    Event Type
    Injury
    Date Received
    April 24, 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 (B)(4) 2015. THE 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 (B)(6) 2015 FROM A REPORTER REPORTING FOR A CONSUMER (AGE AND GENDER UNSPECIFIED) FROM THE UNITED STATES IDENTIFIED BY THE REPORTER VIA AN INTERNET SEARCH. THE MEDICAL HISTORY INCLUDED FACIAL DERMAL FILLERS AND BOTOX. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2009, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER (DOSE, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, FOR THE HOLLOWS UNDER THE EYES AND IN THE NASAL AREA. DURING ADMINISTRATION, THE PLASTIC SURGEON HIT A VEIN THAT LEFT A HEMATOMA AND A BUMP. ON THE SAME DAY, THE CONSUMER STARTED TO DEVELOP LUMPS IN EVERY AREA WHERE THE DEVICE WAS INJECTED. AFTER FIVE MONTHS, THE CONSUMER DEVELOPED GRANULOMA IN THE LEFT EYE CORNER THAT BECAME SWOLLEN. THE CONSUMER DESCRIBED THE GRANULOMA AS A LARGE PEA-SHAPED TYPE CYST, WHICH OOZED LIQUID AND PARTIALLY CLOSED THE EYE. ON AN UNSPECIFIED DATE, THE CONSUMER CONSULTED A PHYSICIAN AND WAS TREATED WITH FIVE CORTISONE INJECTIONS (DOSE, FREQUENCY AND ROUTE UNSPECIFIED), WHICH DECREASED THE SWELLING FOR ONLY ABOUT FOUR DAYS. THE CONSUMER WAS THEN PRESCRIBED WITH ORAL PREDNISONE AND AFTER AN UNSPECIFIED DURATION THE SWELLING RESOLVED BUT DEVELOPED MOON FACE. ON AN UNSPECIFIED DATE, THE CONSUMER WAS ADMINISTERED RESTYLANE (NON-ANIMAL STABILIZED HYALURONIC ACID) (DOSE, FREQUENCY, ROUTE, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) TO MINIMIZE THE BUMPS BUT DEVELOPED AN APPEARANCE OF A RAISED PUFFY SCAR. THE CONSUMER ALSO UNDERWENT FRAXEL LASER SURGERY THAT TIGHTENED THE AREA AROUND THE GRANULOMAS, BUT HAD NO EFFECT ON THE GRANULOMAS. TEN MONTHS AFTER THE DEVICE WAS ADMINISTERED, EACH SITE WAS INJECTED WITH SALINE SOLUTION AND MASSAGED BUT THE BUMPS BECAME MORE PROMINENT AND HARDER. THROUGHOUT THE YEAR POST-ADMINISTRATION, THE CONSUMER HAD FIVE TO SEVEN UNSPECIFIED STEROID INJECTIONS WITH VARIED STRENGTHS (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) TO REVERSE THE GRANULOMAS AND SOME TEMPORARILY REDUCED IT FOR ABOUT 24 TO 48 HOURS. AFTER AN UNSPECIFIED DURATION, THE USE OF THE DEVICE WAS DISCONTINUED. THE ACTIONS TAKEN FOR RESTYLANE AND UNSPECIFIED STEROID WERE UNKNOWN. THE OUTCOME OF THE EVENTS GRANULOMA AND BUMPS RESOLVED WHILE THE OUTCOME OF THE OTHER EVENTS WERE 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 THE COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272710 EVOLENCE COLLAGEN FILLER IMPLANT, DERMAL, FOR AESTHETIC USE LMH COLBAR LIFESCIENCE, LTD EVOLENUS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other