BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOVISC

    MDR report key: 6136334 · Received November 30, 2016

    Report

    Report Number
    3007093114-2016-00030
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    September 7, 2016
    Report Date
    November 30, 2016
    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

    NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AFTER RECEIVING HER FIRST ORTHOVISC INJECTION ON EACH KNEE ON (B)(6) 2016 SHE BEGAN EXPERIENCING HORRIBLE PAIN AND SWELLING ON HER LEGS TO WHERE SHE IS UNABLE TO STRAIGHTEN HER LEGS OUT FOR ABOUT THREE WEEKS. THE PATIENT STATED THAT HER MUSCLES FEEL TIGHT AND CRAMPED TO THE POINT THAT IT IS A STRUGGLE FOR HER TO WALK AND GET OUT OF BED. SHE STATED THAT PAIN IS GOING UP IN TO HER LOWER BACK PLUS SHE IS HAVING HORRIBLE FATIGUE TO WHERE SHE ENDED UP GOING TO THE ER. THE PATIENT REPORTED THAT THEY PUT HER ON PREDNISONE DECREASING PACKAGE AND AS SOON AS SHE WAS DONE WITH THE MEDICINE THE SYMPTOMS CAME BACK. SHE IS STILL HAVING THE SWELLING AND PAIN BUT NOT AS BAD AS BEFORE. THE PATIENT STATED THAT SHE IS BTB ON HER LEFT KNEE AND IS CURRENTLY TAKING ANTI-INFLAMMATORY AND MUSCLE RELAXERS. THE PATIENT IS FOLLOWING UP WITH HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785506 ORTHOVISC SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION MOZ ANIKA THERAPEUTICS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization