BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2030767 · Received March 21, 2011

    Report

    Report Number
    2246315-2011-00053
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    January 1, 2008
    Report Date
    March 10, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PSEUDOSEPSIS [INFLAMMATION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2011 FROM A HEALTHCARE PROFESSIONAL REGARDING A PT, INITIALS UNK, WHO EXPERIENCED PSEUDOSEPSIS AFTER STARTING SYNVISC. THE PT REC'D TREATMENT WITH SYNVISC "THREE YRS AGO." THE HCP DID NOT REPORT HOW MANY INJECTIONS THE PT REC'D. THE HCP REPORTED THAT THE PT DEVELOPED PSEUDOSEPSIS AFTER "REPEAT TREATMENTS" WITH SYNVISC (DATE NOT PROVIDED). THE PT REQUIRED TREATMENT. THE HCP REPORTED THAT THE PT REQUIRED HOSPITALIZATION. THE PRODUCT LOT NUMBER WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS UNK. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization