BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 2163568 · Received June 6, 2011

    Report

    Report Number
    1223628-2011-00018
    Event Type
    Other
    Date Received
    June 6, 2011
    Date of Event
    March 18, 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

    THE PT HAD 3 INJECTIONS OF ORTHOVISC AND COULD NOT STAND DUE TO PAIN AFTER. PHYSICIAN TOLD HER TO STAY WITH PHYSICAL THERAPY.

    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 Required Intervention