BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOVISC

    MDR report key: 3370275 · Received September 19, 2013

    Report

    Report Number
    3007093114-2013-00017
    Event Type
    Injury
    Date Received
    September 19, 2013
    Date of Event
    August 27, 2013
    Report Date
    September 18, 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 BATCH RECORD, INCLUDING STERILITY TESTING RECORDS, WAS REVIEWED AND MET SPECIFICATIONS, AND DID NOT REVEAL ANY ISSUES WITH THE PRODUCT LOT. PRODUCT WAS RETURNED TO ANIKA THERAPEUTICS INC. FOR TESTING ON (B)(4) 2013. MICROBIOLOGY TO PERFORM STERILITY TESTING ON THE RETURNED SAMPLES AND TESTING TO BE COMPLETE ON (B)(4) 2013.

    Description of Event or Problem · 1

    THE PHYSICIAN ASSISTANT FOR THE INJECTING SURGEON REPORTED THAT THE PATIENT HAD HER 1ST UNILATERAL INJECTION IN THE SERIES ON (B)(6) 2013, IN HER LEFT KNEE WITH NO INITIAL SIDE EFFECTS AND DEVELOPED AN UNUSUAL BACTERIAL INFECTION. THE PATIENT RETURNED TO THE DOCTORS OFFICE ON (B)(6) 2013, WITH INCREASED PAIN AND SWELLING IN HER LEFT KNEE. THE PATIENT WAS INITIALLY TREATED WITH THE ORAL ANTIBIOTIC KEFLEX TWICE DAILY AND HOSPITALIZED ON (B)(6) 2013 AND IS NOW RECEIVING THE ANTIBIOTIC UNISON EVERY 6 HOURS BY I.V. THE PA STATED THE PATIENT HAD NO PRIOR KNEE SURGERIES ON THE LEFT KNEE, NO PREEXISTING MEDICAL CONDITIONS AND HAD BEEN RECEIVING ORTHOVISC INJECTIONS IN HER RIGHT KNEE SINCE 2009 WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472406 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR MOZ ANIKA THERAPEUTICS INC. 630-254 N120090A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R ALCOHOL PREP| BETADINE