BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC-ONE 48 MG/6ML

    MDR report key: 3233872 · Received July 12, 2013

    Report

    Report Number
    MW5030917
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    December 28, 2012
    Report Date
    July 12, 2013
    Manufacturer
    GENZYME CORP
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    (B)(6) FEMALE SEEN IN PHYSICIAN'S OFFICE FOR KNEE INJECTION OF SYNVISC ON (B)(6) 2012. ADMITTED TO HOSPITAL ON (B)(6) 2012 WITH PAIN AND SWELLING OF INJECTED KNEE. HAD SURGERY FOR A WASHOUT AND PARTIAL MENISCECTOMY; C AND S OF KNEE ASPIRATE GREW STREPTOCOCCUS MITIS AND STREPTOCOCCUS ORALIS. HAD GOOD OUTCOME FOLLOWING 9 WEEKS OF ANTIBIOTIC THERAPY. THE SYNVISC MAY HAVE BEEN THE SOURCE OF CONTAMINATION. DOSE OR AMOUNT: 48 MG, FREQUENCY: ONCE, ROUTE: INTRA-ARTICULAR. DATES OF USE: ONE-TIME INJECTION (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321913 SYNVISC-ONE 48 MG/6ML NONE MOZ GENZYME CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R