BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2065726 · Received March 29, 2011

    Report

    Report Number
    MW5020311
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 19, 2011
    Manufacturer
    FERRING
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VERY SEVERE PAIN, SWELLING, AND REDNESS OF JOINT AFTER SECOND INJECTION OF EUFLEXXA. THERE MAY HAVE BEEN A MILDER REACTION AFTER THE FIRST INJECTION BUT IT WAS TRANSIENT. PT HAS HAD MULTIPLE COURSES OF TREATMENT WITH SIMILAR DRUGS (BOTH SYNVISC AND SUPARTZ) WITH NO ADVERSE REACTION. PT IS IN SUCH SEVERE PAIN HE CANNOT SLEEP OR WALK. DOCTOR ADVISED TO ATTEMPT TO WALK ON LEG ANYWAY. NOTE: WE ATTEMPTED TO REPORT THIS EVENT TO THE MFR, BUT THEY WOULD NOT TAKE THE REPORT. DOSE: 2ML, FREQUENCY: 2 ONE WEEK APART, ROUTE: 035. DATES OF USE: (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: OSTEOARTHRITIS KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUFLEXXA INJECTION MOZ FERRING UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other