BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 6030314 · Received October 12, 2016

    Report

    Report Number
    MW5065390
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 11, 2016
    Manufacturer
    SANOFI.AVENTIS / GENCYME CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I RECEIVED SYNVISC INJECTIONS IN MY RIGHT KNEE. WITH EACH INJECTION, I SUFFERED FROM FEVER, HEADACHE, EXTRAORDINARY PAIN AND INFLAMMATION AT THE INJECTION SITE, SWEATS, CHILLS AND BODY ACHES. THE COURSE OF TREATMENT IS 3 INJECTIONS. WITH EACH INJECTION, THE SYMPTOMS BECAME MORE SEVERE. FREQUENCY: 1 INJ/WEEK. HOW WAS IT TAKEN OR USED: SUBCUTANEOUS. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2016. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2016. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: YES. REASON FOR USE: OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675800 SYNVISC SYNVISC MOZ SANOFI.AVENTIS / GENCYME CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other ARMOR THYROID| MULTI-VITAMIN