BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1473396 · Received September 11, 2009

    Report

    Report Number
    2032896-2009-00022
    Event Type
    Other
    Date Received
    September 11, 2009
    Report Date
    September 11, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 FEMALE PATIENT (AGE NOT PROVIDED) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE (REPORTED AS A SMALL AMOUNT) ON (B)(6) 2009 TO THE FOLDS OF SKIN ALONGSIDE THE NOSE AND ABOVE THE LIPS. PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNKNOWN DATE, AFTER THE INJECTION, THE PATIENT REPORTED HAVING DIFFICULTY MOVING HER MOUTH AND LIPS, DESCRIBED AS A "FROZEN LOOK". SELF TREATMENT FOR THE EVENT INCLUDED MOVING AND EXERCISING HER MOUTH AND LIPS AS MUCH AS SHE COULD IN AN EXAGGERATED WAY. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED. THE PATIENT CONTACTED THE COMPANY VIA AN E-MAIL. FOLLOW-UP E-MAILS WERE SENT TO THE PATIENT WITH NO RESPONSE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other NOT REPORTED