BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1962916 · Received January 13, 2011

    Report

    Report Number
    2246315-2011-00007
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 7, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PAIN BOTH ABOVE AND BELOW RIGHT KNEE [ARTHRALGIA], SWELLING BOTH ABOVE AND BELOW THE RIGHT KNEE [JOINT SWELLING], HARD TIME WEIGHT BARING ON THE KNEE [WEIGHT BEARING DIFFICULTY]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH A HISTORY OF OSTEOARTHRITIS AND PREVIOUS SYNVISC TREATMENT, WHO EXPERIENCED KNEE PAIN, KNEE SWELLING AND DIFFICULTY BEARING WEIGHT AFTER STARTING SYNVISC-ONE. THE PATIENT RECEIVED ONE INJECTION OF SYNVISC-ONE INTO EACH KNEE ON (B)(6) 2010. THE PATIENT REPORTED THAT HER LEFT KNEE FELT BETTER, BUT SHE EXPERIENCED PAIN AND SWELLING IN HER RIGHT KNEE AS WELL AS DIFFICULTY BEARING WEIGHT ON HER RIGHT LEG (DATE NOT PROVIDED). THE PATIENT REQUIRED TREATMENT FOR HER SYMPTOMS. THE PATIENT REPORTED THAT SHE RECEIVED ONE INJECTION OF CORTISONE INTO HER RIGHT KNEE (DATE NOT PROVIDED). THE PRODUCT LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PATIENT WAS NOT YET RECOVERED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention