BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE, RESTYLANE

    MDR report key: 3925451 · Received July 7, 2014

    Report

    Report Number
    2032896-2014-00491
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDICIS AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT SITE SWELLING, IMPLANT SITE ERYTHEMA, IMPLANT SITE ABSCESS, IMPLANT SITE INFECTION, IMPLANT SITE INFLAMMATION ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2014 FROM A PHYSICIAN AND CONCERNS A (B)(6) YEAR OLD FEMALE PT. NO INFO ABOUT MEDICAL HISTORY, CONCOMITANT MEDICATION, HISTORY OF ALLERGIES OR PREVIOUS FILLER TREATMENTS WAS PROVIDED. ON (B)(6) 2014, THE PT WAS INJECTED WITH RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) (LOT NUMBER 12317-1, 4.5 ML, INJECTION TECHNIQUE UNK) BY AN INDEPENDENT COSMETICIAN IN THE PERIORAL GLABELLA AND FRONT. ON (B)(6) 2014, FIVE DAYS POST INJECTION, THE PT CONSULTED A DERMATOLOGIST AS SHE HAD ONSET OF THE ADVERSE EVENT SWELLING IN THE INJECTION AREA (IMPLANT SITE SWELLING), REDNESS IN THE INJECTION AREA (IMPLANT SITE ABSCESS) IN THE INJECTION AREAS. ON (B)(6) 2014 THE PT WAS HOSPITALIZED. ON (B)(6) 2014, THE FACIAL ABSCESSES WERE REMOVED. ADDITIONAL THERAPY OF THE ADVERSE EVENTS WERE ANALGESIA, SYSTEMIC AND TOPICAL ANTIBIOTICS. ACCORDING TO LABORATORY TESTS THE PT HAD INCREASED LEUCOCYTES, THROMBOCYTES AND CPR C REACTION PROTEIN INDICATING THAT THE PT HAD ONSET OF THE ADVERSE EVENTS INFECTION [IMPLANT SITE INFECTIONS] AND INFLAMMATION [IMPLANT SITE INFLAMMATION] IN THE INJECTED AREAS. THE PT WAS HOSPITALIZED FOR A TOTAL OF TEN NIGHTS. THE OUTCOME FOR SWELLING IN THE INJECTION AREA [IMPLANT SITE SWELLING], REDNESS IN THE INJECTION AREA [IMPLANT SITE ERYTHEMA], FACIAL ABSCESSES [IMPLANT SITE ABSCESS], INFECTION [IMPLANT SITE INFECTION] AND INFLAMMATION [IMPLANT SITE INFLAMMATION] WAS NOT RECOVERED/NOT RESOLVED ON (B)(6) 2014. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT. FOLLOW UP LETTER SENT TO PHYSICIAN ON (B)(6) 2014. FOR REF PURPOSE ONLY, THIS CASE HAS ALSO BEEN ASSIGNED THE FOLLOWING TRACKING NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393142 RESTYLANE, RESTYLANE INJECTABLE DERMAL FILLER LMH MEDICIS AESTHETICS, INC. 00567501 12317-1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization