BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 2163598 · Received June 6, 2011

    Report

    Report Number
    1223628-2011-00017
    Event Type
    Other
    Date Received
    June 6, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    MOZ
    PMA / PMN Number
    030019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE TO BE RETURNED.

    Description of Event or Problem · 1

    AFTER THE SECOND ORTHOVISC INJECTION, THE PT HAD HEAVY SWELLING FROM HIS KNEE DOWN TO HIS ANKLE WITH PAIN. HE WAS DIAGNOSED WITH GOUT AND HOSPITALIZED FOR TWO DAYS. HE HAD HIS 3RD ORTHOVISC INJECTION AND IT WAS WELL TOLERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR MOZ ANIKA THERAPEUTICS, INC. 630-254 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization