BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3254059 · Received July 26, 2013

    Report

    Report Number
    2246315-2013-00410
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    July 18, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # S1222, WITH EXPIRATION DATE (05/01/2015) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC-ONE IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    BAD INFECTION/BACTERIA IN KNEE [RHEUMATOID ARTHRITIS] [BACTERIA INFECTION], LEFT KNEE SWOLLEN [RHEUMATOID ARTHRITIS] [JOINT SWELLING], LEFT KNEE PAINFUL [RHEUMATOID ARTHRITIS] [ARTHRALGIA], LEFT KNEE EFFUSION [RHEUMATOID ARTHRITIS] [JOINT EFFUSION], NOT FEELING WELL [RHEUMATOID ARTHRITIS] [MALAISE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) FEMALE CONSUMER, INITIALS (B)(6), WITH RHEUMATOID ARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF REMICADE AND SYNVISC-ONE (TWO INJECTIONS ABOUT A YEAR APART). ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN GF-20) INJECTION, AT A DOSE OF 6 ML, ONCE, IN LEFT KNEE (ROUTE OF ADMINISTRATION NOT PROVIDED). THE NEXT MORNING (ON (B)(6) 2013) AT 05:00 A.M, THE PATIENT WAS NOT FEELING WELL AND THE LEFT KNEE WAS SWOLLEN AND PAINFUL. FOLLOWING THIS, THE PATIENT WAS TAKEN TO EMERGENCY ROOM AND FLUID WAS REMOVED FROM LEFT KNEE. IT WAS REPORTED THAT THE PATIENT HAD BAD INFECTION/BACTERIA IN HER KNEE AND WAS HOSPITALIZED FOR 9 DAYS. IT WAS REPORTED THAT THE INFECTION HAD DAMAGED THE PATIENT'S KNEE AND THAT WOULD REQUIRE SURGERY. THE OUTCOME FOR THE EVENTS OF BAD INFECTION/BACTERIA IN KNEE, LEFT KNEE SWOLLEN, LEFT KNEE PAINFUL, LEFT KNEE EFFUSION AND NOT FEELING WELL WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC ONE AND ALL THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350997 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK S1222

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R