BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOVISC

    MDR report key: 1081462 · Received July 25, 2008

    Report

    Report Number
    1223628-2008-00005
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    December 4, 2007
    Report Date
    July 25, 2008
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    MOZ
    PMA / PMN Number
    P030019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FORWARDED TO ANIKA THERAPEUTICS BY THE PHARMACOVIGILANCE DEPT OF GENZYME CORP, WHICH WAS INITIALLY SUBMITTED AS AN MDR IN FEBRUARY (REPORT #: 2246315-2008-00023). ACCORDING TO THE HEALTH CARE PROFESSIONAL THAT ADMINISTERED THE INJECTION, THERE WAS AN ERROR RELATED TO THE MFR OF THE PRODUCT THAT WAS ADMINISTERED. INITIALLY, IT WAS THOUGHT THAT SYNVISC WAS USED, BUT SEVERAL MONTHS LATER IT HAS BEEN IDENTIFIED AS ORTHOVISC. UP TO THIS POINT, WE ARE UNCERTAIN OF THE VALIDITY OF THIS CLAIM. ANIKA MADE SEVERAL ATTEMPTS TO CONFIRM THIS CLAIM, BUT HAVE NOT RECEIVED ANY EVIDENCE TO SUGGEST IF ORTHOVISC WAS INVOLVED IN THIS EVENT. NO LOT NUMBER OR OTHER DOCUMENTATION HAS BEEN OFFERED TO SUBSTANTIATE THIS CLAIM. WE ARE SUBMITTING THIS MDR REPORT TO COMPLY WITH THE REPORTING REQUIREMENTS TO ENSURE, IT IS REPORTED WITH THE CURRENT INFO WE HAVE ON FILE.

    Description of Event or Problem · 1

    PT DEVELOPED PAIN AND SWELLING IN HIS ANKLE, RIGHT CALF, AND KNEE CAP. THE PT WAS HOSPITALIZED FOR NINE DAYS DUE TO A BLOOD CLOT IN HIS RIGHT LEG THAT WAS PREVIOUSLY REPORTED AS HAVING THE SWOLLEN CALF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization