BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2163645 · Received June 10, 2011

    Report

    Report Number
    2246315-2011-00135
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 3, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Description of Event or Problem · 1

    OEDEMA IN RIGHT KNEE [OEDEMA PERIPHERAL]. PAIN IN RIGHT KNEE [ARTHRALGIA]. FLUID WAS ASPIRED FROM RIGHT KNEE [JOINT EFFUSION]. KNEE SWELLING [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM A WHOLESALER REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH KNEE PAIN, KNEE EFFUSION, KNEE SWELLING AND OEDEMA IN THE RIGHT KNEE. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR GONARTHROSIS IN THE RIGHT KNEE. ON (B)(6) 2011, THE PT RECEIVED THE FIRST INJECTION OF SYNVISC IN HER RIGHT KNEE. ON (B)(6) 2011, THE PT DEVELOPED KNEE PAIN AND KNEE SWELLING. SYNVISC TREATMENT WAS PERMANENTLY STOPPED. ON (B)(6) 2011, PT HAD 20CC OF "YELLOW OPACITY FLUID" ASPIRATED FROM HER RIGHT KNEE. ALSO ON (B)(6) 2011, THE PT'S SYMPTOMS WERE TREATED WITH BETAMETHASONE SODIUM PHOSPHATE (DETAILS NOT PROVIDED). THE PRODUCT LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention