BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INEJCTABLE GEL

    MDR report key: 1473402 · Received September 10, 2009

    Report

    Report Number
    2032896-2009-00020
    Event Type
    Other
    Date Received
    September 10, 2009
    Date of Event
    August 6, 2009
    Report Date
    September 9, 2009
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): P020023. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNKNOWN.

    Description of Event or Problem · 1

    ON 08/31/2009, A SPONTANEOUS REPORT WAS RECEIVED REGARDING A (B) (6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED PREVIOUS INJECTIONS OF BOTOX (BOTULINUM TOXIN TYPE A) WITH NO ADVERSE REACTION. THE PATIENT HAD NOT BEEN INJECTED WITH RESTYLANE PREVIOUSLY AND WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE ON (B) (6) 2009 TO THE LIPS AND UNDER THE EYES. PRE-PROCEDURE MEDICATIONS INCLUDED AN UNSPECIFIED INJECTABLE NUMBING AGENT ADMINISTERED TO THE LIPS. ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED BOTOX INJECTION AROUND THE EYES. ON APPROXIMATELY (B) (6) 2009, WITHIN 2 DAYS OF THE INJECTION, THE PATIENT DEVELOPED AN ITCH ON HER CHEST AND BACK. THE PATIENT VISITED A PHYSICIAN AND WAS DIAGNOSED WITH AN ALLERGIC REACTION (CAUSE OF THE ALLERGIC REACTION UNKNOWN). THE PATIENT WAS GIVEN AN UNSPECIFIED FOAM AND LOTRIMIN (CLOTRIMAZOLE). AROUND THE SAME TIME (DATE UNSPECIFIED), THE PATIENT ALSO NOTED NUMBING AND TINGLING DOWN HER RIGHT ARM THAT WOULD COME AND GO. THE PATIENT DID NOT RECEIVE ANY TREATMENT FOR THESE SYMPTOMS. THE REPORTER STATED THAT THE PHYSICIAN DID NOT EVEN KNOW ABOUT THESE SYMPTOMS AND REFUSED TO PROVIDE PHYSICIAN CONTACT INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other