BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 2093861 · Received April 22, 2011

    Report

    Report Number
    1223628-2011-00015
    Event Type
    Other
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 31, 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 FIRST INJECTION OF THE ORTHOVISC, 45 MINUTES LATER, THE PT DEVELOPED A RASH, THROAT AND TONGUE SWELLING. SHE WENT TO THE RR AND WAS TREATED WITH 74 MG OF PREDISONE. HER RASH AND SWELLING DIMINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR MOZ ANIKA THERAPEUTICS, INC. 630-254 N100094A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention