BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1023734 · Received March 28, 2008

    Report

    Report Number
    9710154-2008-00003
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 18, 2008
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT OF NON-SERIOUS, UNLABELED EVENTS (PAIN, CHILLS) IS BEING SUBMITTED AS A 10-DAY REPORT. INFORMATION WAS RECEIVED FROM AN ESTHETICIAN REGARDING A FEMALE PATIENT WHO RECEIVED INJECTIONS OF RESTYLANE INJECTABLE GEL (INJECTABLE DERMAL FILLER) INTO THE WRINKLES ABOVE HER LIPS IN 2008. TOPICAL BENZOCAINE/LIDOCAINE/TETRACAINE WAS ADMINISTERED AS AN ANESTHETIC PRE-PROCEDURE. MEDICAL HISTORY INCLUDED LASER PROCEDURES AND JUVEDERM (HYALURONIC ACID) ON UNSPECIFIED DATES. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON THE NEXT DAY, THE PATIENT DEVELOPED SWELLING JUST BELOW THE TREATED AREA (INJECTION SITE SWELLING) AND WAS TREATED WITH INTRAMUSCULAR DEXAMETHASONE SODIUM PHOSPHATE INJECTION. FOUR DAYS LATER, THE PATIENT WAS SEEN IN THE OFFICE AND THE SWELLING HAD MIGRATED TO THE LOWER LIP AREA BELOW THE INJECTION SITE. A WEEK LATER, THE PATIENT EXPERIENCED BODY ACHES (PAIN), CHILLS (CHILLS), AND PAIN DESCRIBED AS "KNIFE TYPE BURNING PAIN" AT THE INJECTION SITE (IMPLANT SITE PAIN). THE PATIENT WAS PRESCRIBED A MEDROL (METHYLPREDNISOLONE) DOSPAK. AS OF THE NEXT DAY, THE EVENTS PERSISTED. THE RESTYLANE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS 9134 AND 02/2010, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9134

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR