BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2114258 · Received May 25, 2011

    Report

    Report Number
    2032896-2011-00035
    Event Type
    Other
    Date Received
    May 25, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA 510(K)#: P040024.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A SPONTANEOUS REPORT WAS RECEIVED VIA EMAIL FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE (AGE NOT REPORTED) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED SLIGHTLY ELEVATED BLOOD PRESSURE. THE PATIENT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE (SYRINGE SIZE USED AND AMOUNT INJECTED NOT REPORTED) ON AN UNSPECIFIED DATE IN (B)(6) 2011 (REPORTED AS "LAST MONTH" FROM THE DATE OF THE REPORT) AROUND THE MOUTH AREA. PRE-PROCEDURE MEDICATIONS USED AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2011 OR (B)(6) 2011, AFTER THE IMPLANTATION, THE PATIENT'S BLOOD PRESSURE "WENT PRETTY HIGH 200/117" WHICH LASTED ABOUT TWO DAYS. THE PATIENT REPORTED ASKING THE DERMATOLOGIST BEFORE TREATMENT IF RESTYLANE CAUSED ELEVATED BLOOD PRESSURE AND THE PATIENT REPORTED HE SAID, "NO." THE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN