BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 1914467 · Received November 23, 2010

    Report

    Report Number
    1223628-2010-00127
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    MOZ
    PMA / PMN Number
    030019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE TO BE RETURNED.

    Description of Event or Problem · 1

    PT WAS INJECTED WITH ORTHOVISC AND HAD SOME SLIGHT SWELLING A FEW HOURS LATER. THE FOLLOWING DAY A STEROID INJECTION WAS GIVEN IN ORDER TO REDUCE THE SWELLING. IT WAS DESCRIBED BY THE PHYSICIAN AS AN ALLERGIC REACTION HE HAS SEEN IN OTHER VISCO-ELASTIC SUPPLEMENT. AFTER THE STEROID INJECTION, THE SWELLING WENT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR MOZ ANIKA THERAPEUTICS, INC. 630-254 N100001A

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Required Intervention