BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOVISC

    MDR report key: 2960657 · Received February 12, 2013

    Report

    Report Number
    3007093114-2013-00004
    Event Type
    Other
    Date Received
    February 12, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 12, 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 4 ORTHOVISC INJECTIONS. THE FIRST INJECTION WAS ON (B)(6) 2012 AND THE NEXT 3 SHOTS A WEEK APART. THE PATIENT REPORTED BACK PAIN 3-4 DAYS AFTER 1ST INJECTION. UPDATED (B)(6) 2013 - PATIENT STATED HIS BACK PAIN WAS SEVERE. THE PAIN STARTED APPROXIMATELY 3 DAYS AFTER HIS FIRST INJECTION AND PROGRESSIVELY WORSENED. THE PATIENT REPORTED THE BACK PAIN GOES DOWN HIS LEFT BUTTOCKS THEN CONTINUES DOWN HIS LEG TO HIS CALF. THE PATIENT SUSPECTED A SCIATIC NERVE PROBLEM AND WENT TO A CHIROPRACTOR WITH NO RELIEF. THE PATIENT'S ORTHOPEDIC DOCTOR PRESCRIBED PREDNISONE, CELEBREX AND FLEXURAL. PATIENT ALSO REPORTS HE RECEIVED A STEROID SHOT IN THE LEFT BUTTOCKS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60363 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR MOZ ANIKA THERAPEUTICS INC. 630-254 N120080A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention