BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3232259 · Received July 9, 2013

    Report

    Report Number
    2032896-2013-00282
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    June 10, 2013
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENT: IT WAS REPORTED THE PT RECEIVED RESTYLANE. THE LOT NUMBER 11414 AND EXPIRATION DATE 10/2013, ARE VALID FOR RESTYLANE-L (CROSS LINKED HYALURONIC ACID DERMAL FILLER-LIDOCAINE). FOR REFERENCE PURPOSES ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBERS: XCE-63306-AE (MEDCOMM SOLUTIONS ON BEHALF OF (B)(4)). PHARMACOVIGILANCE COMMENT: PB (B)(6) 2013. INFECTION, FACIAL DEPRESSIONS, DEVICE DISLOCATION ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6)2013 FROM A (B)(6) YEAR OLD FEMALE PT. THE PT HAD A MEDICAL HISTORY OF COSMETIC USE. CONCOMITANT MEDICATIONS INCLUDED PREMARIN. ON (B)(6) 2012, THE PT WAS ADMINISTERED WITH RESTYLANE (CROSS LINKED HYALURONIC ACID DERMAL FILLER) INTRADERMALLY TO THE FACE FOR A COSMETIC USE. THE BATCH NUMBER USED WAS 11414 AND EXPIRATION DATE WAS 10/2013. SOMETIME IN (B)(6) 2012, THE PT DEVELOPED A "DRAINING INFECTION" AT THE SITE OF INJECTION. THE PT STATES THAT AT THE TIME OF THIS REPORT, HER FACE HAS DEPRESSIONS AND THE RESTYLANE "FLOATS" AROUND HER FACE. THE OUTCOME OF THE EVENT WAS RECOVERING. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312693 RESTYLANE L, RESTYLANE LIDOCAINE NONE LMH MEDICIS AESTHETICS, INC. 11414

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other