BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2851117 · Received November 16, 2012

    Report

    Report Number
    2246315-2012-00353
    Event Type
    Other
    Date Received
    November 16, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLERGIC REACTION [HYPERSENSITIVITY]. MASSIVE INTRA-ARTICULAR EFFUSION ON BOTH SIDES [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 (ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012) FROM A PHYSICIAN VIA SALES REPRESENTATIVE REGARDING A (B)(6) WITH GONARTHROSIS OF BOTH KNEES. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT INITIATED INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION INTO BOTH KNEES (DOSE AND FREQUENCY NOT PROVIDED). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT RECEIVED SECOND INJECTION OF SYNVISC INTO BOTH KNEES. ON AN UNSPECIFIED DATE IN 2012, THE PATIENT EXPERIENCED ALLERGIC REACTION. IT WAS REPORTED THAT ON (B)(6) 2012 (APPROXIMATELY 07 HOURS AFTER THE INJECTION), THE PATIENT HAD MASSIVE INTRA-ARTICULAR EFFUSION ON BOTH SIDES AND 60 ML OF TURBID, SERIOUS EXUDATE WAS ASPIRATED PER EACH KNEE AFTER INTRA-ARTICULAR APPLICATION OF LIPOTALON (DEXAMETHASONE PALMITATE). ON THE NEXT DAY, THE PATIENT RECEIVED PIROXICAM AND INTRA-ARTICULAR DEXAMETHASONE INJECTION AND RECOVERED FROM JOINT EFFUSION. SYNVISC TREATMENT WAS PERMANENTLY DISCONTINUED. THE OUTCOME FOR THE EVENT OF ALLERGIC REACTION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF ALLERGIC REACTION AND JOINT EFFUSION WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF THE JOINT EFFUSION WAS ASSESSED AS DEFINITE. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF ALLERGIC REACTION WAS NOT PROVIDED BY THE REPORTER.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention