BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1398366 · Received June 3, 2009

    Report

    Report Number
    2032896-2009-00012
    Event Type
    Other
    Date Received
    June 3, 2009
    Date of Event
    March 31, 2009
    Report Date
    June 2, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATING PHYSICIANS (UNSPECIFIED) INFORMED THE PATIENT THAT THIS CAN BE DUE TO POOR ARTERIAL FLOW TO THE OPTIC NERVE. THE LOT NUMBERS WERE REPORTED AS "11" AND "12," WHICH ARE NOT VALID LOT NUMBERS. THE EXPIRATION DATES WERE NOT REPORTED. THE REPORTER REFUSED TO PROVIDE HEALTH CARE PROFESSIONAL CONTACT INFORMATION OR FURTHER PERSONAL INFORMATION. FOLLOW UP WILL BE ATTEMPTED. ADD'L - P020023.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A SPONTANEOUS REPORT WAS RECEIVED REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). THE PATIENT HAD NO SIGNIFICANT MEDICAL HISTORY AND WAS NOT TAKING ANY CONCOMITANT PRESCRIPTION MEDICATIONS OR SUPPLEMENTS. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE, 2 CC TOTAL (2 SYRINGES), ON (B)(6) 2009 TO THE NASOLABIAL FOLDS AND ALONG THE JAW LINE. PRE-PROCEDURE MEDICATIONS INCLUDED A TOPICAL NUMBING AGENT (UNSPECIFIED). NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2009, RIGHT AWAY ON THE DAY OF THE INJECTION, THE PATIENT EXPERIENCED SWELLING, REDNESS, AND BRUISING. WITHIN A COUPLE OF DAYS OF THE INJECTION, THE PATIENT NOTICED SOME BLURRED VISION ON THE RIGHT SIDE. THE PATENT INITIALLY THOUGHT THAT THE BLURRED VISION WAS RELATED TO THE SWELLING, BUT NOTED THAT HER RIGHT EYE WAS VERY SENSITIVE AND HURT WHEN LOOKING INTO THE LIGHT. EVEN AFTER THE SWELLING WENT DOWN, THE PATIENT WENT FROM HAVING 20/20 VISION IN HER RIGHT EYE TO NOT BEING ABLE TO SEE MORE THAN THE "BIG E ON THE EYE TEST" IN THE BEGINNING OF (B)(6) 2009. THE PATIENT WAS EVALUATED BY AN OPTOMETRIST, AN OPHTHALMOLOGIST, A NEURO-OPHTHALMOLOGIST, A NEUROLOGIST, AND BY CARDIOLOGY. THE PATIENT UNDERWENT AN ULTRASOUND OF THE CAROTID ARTERIES, AN ECHOCARDIOGRAM, MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN AND ORBITS WITH CONTRAST, AND A BLOOD TEST TO RULE OUT ANTINUCLEAR ANTIBODIES (ANA) IN (B)(6) 2009 (RESULTS NOT REPORTED). THE PATIENT WAS DIAGNOSED WITH INFLAMMATION AND SWELLING OF THE OPTIC NERVE. THE PATIENT DID NOT RECEIVE TREATMENT. THE BRUISING AND REDNESS LASTED A COUPLE OF WEEKS IN THE WHOLE INJECTED AREA. BY (B)(6) 2009, THE PATIENT STILL FELT SLIGHTLY SWOLLEN IN THE RIGHT CHEEK AREA.

    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 54 YR Other NO PRESCRIPTION MEDICATIONS OR SUPPLEMENTS