BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE L, RESTYLANE LIDOCAINE

    MDR report key: 3963986 · Received July 14, 2014

    Report

    Report Number
    2032896-2014-00528
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6), 2014 FROM A (B)(6) FEMALE PATIENT. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6), 2014, THE PATIENT STARTED TREATMENT WITH RESTYLANE L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3$ LIDOCAINE) INJECTION UNDER THE EYES FOR AN UNKNOWN INDICATION. WITHIN 48 HOURS, THE PATIENT'S FACE COMPLETELY SWELLED UP AND HER EYES WERE COMPLETELY CLOSED. THE PATIENT HAD TO GO TO EMERGENCY ROOM. THE PATIENT WAS GIVEN STEROID INJECTION ON THE EMERGENCY ROOM AND THEN WAS TREATED WITH ORAL STEROIDS FOR 5 DAYS. THE PATIENT'S SWELLING COMPLETELY RESOLVED AFTER THE FIVE DAYS OF TREATMENT. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE. FOLLOW UP REQUEST HAS BEEN SENT TO PHYSICIAN ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409753 RESTYLANE L, RESTYLANE LIDOCAINE INJECTABLE DERMAL FILLER LMH MEDICIS AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other