BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1061713 · Received June 17, 2008

    Report

    Report Number
    2246315-2008-00085
    Event Type
    Other
    Date Received
    June 17, 2008
    Date of Event
    March 26, 2008
    Report Date
    June 11, 2008
    Manufacturer
    GENZYME CORPORATION (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REDNESS OF BOTH KNEES [ERTHEMA], SWELLING IN BOTH KNEES [JOINT SWELLING], PAIN IN BOTH KNEES [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 11-JUN-2008 FROM A (B) (6) CONSUMER WITH A HISTORY OF OSTEOARTHRITIS AND PREVIOUS SYNVISC INJECTIONS, (B) (6), WHO EXPERIENCED PAIN IN BOTH KNEES, SWELLING IN BOTH KNEES AND REDNESS IN BOTH KNEES AFTER STARTING SYNVISC. THE PT RECEIVED SYNVISC INJECTIONS INTO BOTH KNEES ON (B) (6) 2008, (B) (6) 2008 AND (B) (6) 2008. SHE STATED THAT SHE EXPERIENCED SOME SORENESS IN BOTH KNEES AFTER THE SECOND SYNVISC INJECTION ON (B) (6) 2008, BUT THAT IT WAS NOT DEBILITATING. HOWEVER, ON (B) (6) 2008, 24 HOURS AFTER THE THIRD INJECTION, SHE EXPERIENCED EXTREME PAIN, REDNESS AND SWELLING IN BOTH KNEES. SHE CONTACTED THE PHYSICIAN WHO PRESCRIBED FOR BOTH KNEES: ICE, ELEVATION, REST AND UNSPECIFIED ORAL STEROIDS FOR A FEW DAYS. BY (B) (6) 2008, THE PT STATED SHE FELT FINE AND WAS ABLE TO MOVE AROUND. THE PT CONTACTED THE MFR TO SEE IF SHE HAD DEVELOPED AN ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R