BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 2068844 · Received April 14, 2011

    Report

    Report Number
    2032896-2011-00024
    Event Type
    Other
    Date Received
    April 14, 2011
    Report Date
    April 5, 2011
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): P040024.

    Description of Event or Problem · 1

    ON 05-APR-2011, A SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE REGARDING A FEMALE (AGE NOT REPORTED) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILTER). MEDICAL HISTORY INCLUDED LUPUS. THE PT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNK DATE, THE PT RECEIVED AN INJECTION OF RESTYLANE (AMOUNT INJECTED NOT REPORTED) TO AN UNSPECIFIED AREA. PRE-PROCEDURE MEDICATIONS USED AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNK DATE, AFTER THE IMPLANTATION, THE PT EXPERIENCED A "LUPUS FLARE-UP." THE NURSE DID NOT COMMENT ON THE CAUSALITY OR SEVERITY OF THE REPORTED EVENTS. THE NURSE REFUSED TO PROVIDE FURTHER INFO "BECAUSE HER INFO WAS ANECDOTAL." THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED.

    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 PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN