BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE

    MDR report key: 768967 · Received October 11, 2006

    Report

    Report Number
    MW1040644
    Event Type
    Other
    Date Received
    October 11, 2006
    Date of Event
    January 29, 2005
    Report Date
    April 12, 2005
    Manufacturer
    MEDICIS AESTHETICS INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN INJECTION OF RESTYLANE WITH ADVERSE REACTION THAT WAS NOT EXPLAINED OR HAD ANY KNOWLEDGE OF. DISFIGURING AND EXTREMELY PAINFUL. COULD NOT GET ANY ANSWERS FROM ADMINISTERING DOCTOR OR COMPANY PRESCRIBING PRODUCT ON WHAT TO EXPECT, FOR HOW LONG I WOULD LOOK AND FEEL LIKE THIS OR ANY POSITIVE COUNTER ACTIONS TO TAKE. FEEL THE PRODUCT WAS GROSSLY NEGLIGENT IN ITS ADVERTISING AND KNOWLEDGE BASE AND IN REACTIONS AND SOLUTIONS FOR USING THE PRODUCT. IT DOES NOT PROVIDE HONEST INFORMATION ON ALL NEGATIVE POSSIBILITIES THEREFORE HAVING THE CONSUMER UNABLE TO MAKE THE WISEST DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE * LMH MEDICIS AESTHETICS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other PREDNISONE PROGRAM