BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 1044675 · Received May 12, 2008

    Report

    Report Number
    MW5006857
    Event Type
    Other
    Date Received
    May 12, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    LZX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALLERGIC REACTION. I HAVE HIVES ALL OVER MY BODY. PA AT CLINIC DID NOT SEEM TO THINK MY COMPLAINTS OF ITCHING AFTER THE FIRST SHOT IN 2008. SECOND SHOT ON A WEEK LATER. RASH ALL OVER BODY APPEARED THE NEXT DAY, WORSENING ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOVISC NONE LZX ANIKA THERAPEUTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other