BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1910546 · Received November 19, 2010

    Report

    Report Number
    2246315-2010-00232
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 11, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IRRITATION IN THE KNEE [ARTHROPATHY]. PAIN IN KNEE [ARTHRALGIA]. SWOLLEN KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN VIA A COMPANY SALES REPRESENTATIVE REGARDING A FEMALE PATIENT, INITIALS (B)(6), WITH A MEDICAL HISTORY OF KNEE ARTHROSIS. THE PATIENT WAS ADMINISTERED THE FIRST SYNVISC INJECTION ON (B)(6) 2010, THE SECOND ON AN UNKNOWN DATE IN (B)(6) 2010, AND THE THIRD INJECTION ON (B)(6) 2010. AFTER THE THIRD INJECTION ON A WEEKEND IN (B)(6) 2010, THE PATIENT EXPERIENCED KNEE PAIN AND IRRITATION IN THE KNEE AND WENT TO THE HOSPITAL. A BACTERIAL TEST WAS NEGATIVE, AND THERE WAS NO RESULT AFTER AN ARTHROSCOPY. ON AN UNKNOWN DATE IN 2010, THE PATIENT RECOVERED AND WAS FREE OF PAIN. THE SYNVISC LOT NUMBER WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2010 FROM THE PHYSICIAN. THE PHYSICIAN CONFIRMED THAT THE (B)(6) PATIENT HAD KNEE ARTHROSIS AND RECEIVED ALL THREE SYNVISC INJECTIONS. THE PATIENT EXPERIENCED SWOLLEN KNEE AND KNEE PAIN. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF SWOLLEN KNEE PAIN WAS "DEFINITE." THE ACTION TAKEN REGARDING SYNVISC WAS NONE. THE OUTCOME FOR THESE TWO EVENTS WERE RECOVERED WITHOUT SEQUELAE. THE SEVERITY WAS SEVERE. THE SYNVISC LOT NUMBER WAS X0909, EXPIRATION DATE OCT-2012. NO FURTHER INFORMATION WAS PROVIDED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    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 67 YR Hospitalization