BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 3012630 · Received March 15, 2013

    Report

    Report Number
    3007093114-2013-00006
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 15, 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. THE BATCH RECORD, INCLUDING STERILITY TESTING RECORDS, WAS REVIEWED AND MET SPECIFICATIONS, AND DID NOT REVEAL ANY ISSUES WITH THE ALLEGED PRODUCT LOT.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED FIRST ORTHOVISC INJECTION ON (B)(4) 2013, THE PATIENT HAD SWELLING IN THE KNEE. ON (B)(6) 2013, THE KNEE WAS ASPIRATED AND SAMPLE SENT TO THE LAB (CRYSTAL ANALYSIS ON THE FLUID AND THE FOLLOWING RESULTS CAME BACK) - IRREGULAR TO AMORPHOUS REFRACTILE CRYSTALLOID FRAGMENTS NOT CONSISTENT WITH URIC ACID OR CA PYROPHOSPHATE. THE PATIENT HAD AN ALCOHOL PREP, 1CC OF LIDOCAINE SUB-Q AND INTO THE JOINT PRIOR TO THE OV INJECTION. THE KNEE WAS ASPIRATED AGAIN (20CC ASPIRATED) AND RAN ANOTHER CULTURE. UPDATED (B)(6) 2013: LAB RESULTS FROM SECOND INJECTION-NO CRYSTALS LISTED. ALL OTHER LABS WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110394 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR MOZ ANIKA THERAPEUTICS INC. 630-254 N120086A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention