BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC-ONE (HYLAN G-F 20) INJECTION 6/ML

    MDR report key: 1912799 · Received November 3, 2010

    Report

    Report Number
    2246315-2010-00225
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 27, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    KNEE WAS SWOLLEN [JOINT SWELLING]. PUNCTURE [JOINT EFFUSION]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM THE HCP OF A (B)(6) FEMALE PT WITH A HISTORY OF RETROPATELLAR ARTHROSIS OF THE KNEE, INITIALS (B)(6), WHO EXPERIENCED A SWOLLEN KNEE AND A KNEE EFFUSION AFTER RECEIVING SYNVISC-ONE. THE PT RECEIVED SYNVISC-ONE (EXACT KNEE NOT KNOWN) ON (B)(6) 2010. THE PT WENT BACK TO THE HCP'S OFFICE ON (B)(6) 2010 BECAUSE THE TREATED KNEE WAS SWOLLEN. A PUNCTURE OF THE KNEE WAS PERFORMED ON (B)(6) 2010 AND 30ML OF CLEAR YELLOW FLUID WAS ASPIRATED. THE PT WAS GIVEN AN INJECTION OF CORTISONE TRIAM 20MG. IN THE OPINION OF THE HCP, THE EVENT OF KNEE EFFUSION WAS "MODERATE" IN INTENSITY AND WAS 'DEFINITELY" RELATED TO THE USE OF SYNVISC-ONE. ALSO, AT THE TIME OF THIS REPORT THE OUTCOME IN THE PT WAS "NOT YET RECOVERED." MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC-ONE (HYLAN G-F 20) INJECTION 6/ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R