BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION 2ML

    MDR report key: 972318 · Received December 28, 2007

    Report

    Report Number
    2246315-2007-00111
    Date Received
    December 28, 2007
    Date of Event
    November 9, 2006
    Report Date
    December 14, 2007
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANAPHYLACTIC REACTION [ANAPHYLACTIC REACTION]. DIFFUSE RASH [RASH GENERALISED]. FACIAL EDEMA [FACE OEDEMA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 14-DEC-2007 FROM A PHYSICIAN VIA A MEDWATCH FORM REGARDING A PATIENT. THE PATIENT RECEIVED THE FIRST DOSE OF SYNVISC ON AN UNKNOWN DATE ADMINISTERED VIA INTRA-ARTICULAR ROUTE AT A DOSE OF 2 ML, 1X/W. THE PATIENT'S MEDICAL HISTORY IS NOT AVAILABLE. IN 2006, THE PATIENT EXPERIENCED AN ANAPHYLACTIC REACTION WITH DIFFUSE RASH AND FACIAL EDEMA THAT WAS UNKNOWN IN INTENSITY AND MEDICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION 2ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK X0520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other