BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2890997 · Received December 26, 2012

    Report

    Report Number
    2246315-2012-00389
    Event Type
    Other
    Date Received
    December 26, 2012
    Date of Event
    January 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BACK PAIN. KNEE STARTED GETTING WORSE. [ARTHROPATHY]. SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A FEMALE PATIENT, INITIALS (B)(6), WITH UNK PRODUCT INDICATION. THE PATIENT¿S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN 2012, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G F 20) INJECTION, ROUTE AND DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN 2012, PATIENT RECEIVED THIRD SYNVISC INJECTION. IT WAS REPORTED THAT THE PATIENT WAS HAVING GOOD RESULTS. ON AN UNSPECIFIED DATE, THE PATIENT VISITED EMERGENCY ROOM (ER) FOR BACK PAIN AND RECEIVED TREATMENT WITH STEROID INJECTION IN THE BUTTOCKS. IT WAS REPORTED THAT AFTER THAT, HER KNEES STARTED GETTING WORSE. THE OUTCOME FOR THE EVENTS OF BACK PAIN AND KNEE STARTED GETTING WORSE WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF BACK PAIN AND KNEE STARTED GETTING WORSE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention