BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1880418 · Received October 8, 2010

    Report

    Report Number
    2246315-2010-00205
    Event Type
    Other
    Date Received
    October 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 6, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POSITIVE FOR STAPHYLOCOCCUS INFECTION (KNEE) [ARTHRITIS INFECTIVE]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON 16-OCT-2010 FROM AN HCP VIA A COMPANY REPRESENTATIVE REGARDING A MALE PATIENT (NAME AND AGE UNKNOWN), WHO EXPERIENCED A STAPHYLOCOCCUS INFECTION IN THE KNEE AFTER RECEIVING SYNVISC-ONE. THE PATIENT RECEIVED SYNVISC-ONE IN BOTH THE KNEES ON (B)(6) 2010 FOR AN UNKNOWN INDICATION. A FEW DAYS AFTER RECEIVING THE INJECTIONS, THE PATIENT WENT BACK TO THE HCP AND HAD ONE KNEE CULTURED WHICH CAME BACK NEGATIVE FOR INFECTION. APPROXIMATELY 12 DAYS LATER, THE PATIENT HAD THE SAME KNEE CULTURED AGAIN AND IT WAS POSITIVE FOR STAPHYLOCOCCUS INFECTION REQUIRING THE KNEE TO BE CLEANED OUT TWICE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN. 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 UNK Other| R