BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1416656 · Received May 1, 2009

    Report

    Report Number
    2032896-2009-00005
    Event Type
    Other
    Date Received
    May 1, 2009
    Date of Event
    April 7, 2009
    Report Date
    April 30, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K)#: P020023.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED CANCER OF THE THYROID, HYPOTHYROIDISM, HERPES LABIALIS, AND PREVIOUS RESTYLANE, PERLANE, AND JUVEDERM IMPLANTATION WITH NO REACTIONS. CONCOMITANT MEDICATIONS INCLUDED SYNTHROID (LEVOTHYROXINE SODIUM). DATES OF THERAPY AND DOSE WERE NOT REPORTED. THE PT RECEIVED A 1 ML INJECTION OF RESTYLANE, MIXED WITH EPINEPHRINE AND LIDOCAINE, ON (B)(6) 2009 BILATERALLY TO MARIONETTE LINES AND ALONG THE PREGEL SULCUS USING A FANNING AND CROSS HATCHING TECHNIQUE. PRE-PROCEDURE MEDICATIONS INCLUDED VALTREX (VALACYCLOVIR HYDROCHLORIDE) AND ANESTHESIA IN THE FORM OF TOPICAL LIDOCAINE AND PRILOCAINE. ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED AN INJECTION OF 8 UNITS OF BOTOX TOT HE DEPRESSOR ANGULARIS MUSCLE. ON (B)(6) 2009, 4 TO 5 HOURS AFTER IMPLANTATION, THE PT DEVELOPED WELTS IN THE TREATMENT AREAS AND OTHER UNSPECIFIED AREAS OF FACE, ALONG WITH DIFFICULTY BREATHING AND SWALLOWING. SHE DIDN'T SEEK CARE AT AN EMERGENCY ROOM. THE PT'S HUSBAND, A PEDIATRIC SURGEON, GAVE HER TAVIST (CLEMASTINE) AND HER SYMPTOMS RESOLVED SHORTLY THEREAFTER WITH NO FURTHER SEQUELAE. ON (B)(6) 2009, THE PHYSICIAN NOTED THAT NO DIAGNOSIS HAD BEEN MADE AND THAT THE PT HAD BEEN REFERRED TO AN ALLERGIST. FOLLOW UP IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA 9561

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR SYNTHROID (LEVOTHYROXINE SODIUM)