BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOVISC

    MDR report key: 2926173 · Received January 16, 2013

    Report

    Report Number
    3007093114-2013-00001
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 16, 2013
    Manufacturer
    ANIKA THERAPEUTICS INC.
    Product Code
    MOZ
    PMA / PMN Number
    P030019
    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 AND THE LOT NUMBER IS UNK. NO FURTHER EVALUATION OR INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2012 - 1ST BILATERAL ORTHOVISC INJECTION - NO ADVERSE REACTION. ON (B)(6) 2012 - 2ND BILATERAL ORTHOVISC INJECTION - PA INJECTED THE LEFT KNEE, THE PT MOVED DUE TO PAIN AND THE NEEDLE CAME OUT OF THE KNEE WHICH CAUSED THE LIQUID TO DRIPPED TO THE FLOOR. THE PA RE-INJECTED THE REMAINING PRODUCT INTO THE SAME KNEE. PT SUFFERED FROM SEVERE SWELLING, BRUISING AND HEART PALPITATIONS POST INJECTION. ON (B)(6) 2012 - THE PT WAS HOSPITALIZED, RECEIVED AN OPERATION FOR STRANGULATION OF THE BOWELS AND SUFFERED A HEART ATTACK/STROKE. ON (B)(6) 2012 - THE PT RETURNED TO HER ATTENDING PHYSICIAN WHO CONFIRMED HIS CLAIM REGARDING TO PRODUCT BEING INJECTED INTO AN ARTERY OR VEIN. PT DID NOT RECEIVE THE 3RD INJECTION OF ORTHOVISC DUE TO SWELLING IN THE KNEE AND WAS PRESCRIBED METHYL PREDNISONE. TO DATE, THE PT IS RECEIVING REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24487 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR MOZ ANIKA THERAPEUTICS INC. 630-254

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R