BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 2001346 · Received February 18, 2011

    Report

    Report Number
    1223628-2011-00005
    Event Type
    Other
    Date Received
    February 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    MOZ
    PMA / PMN Number
    030019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD CLICKING AND PAIN FOLLOWING A SERIES OF ORTHOVISC INJECTIONS. PATIENT HAD X-RAY AND DID NOT SHOW ANY STRUCTURAL DAMAGE. THE PHYSICIAN PRESCRIBED IBUPROFEN FOR PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R