BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1689955 · Received April 12, 2010

    Report

    Report Number
    2246315-2010-00074
    Event Type
    Injury
    Date Received
    April 12, 2010
    Date of Event
    February 9, 2010
    Report Date
    April 1, 2010
    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

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# V0918, EXPIRY DATE 08/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    SEVERE REACTION TO SYNVISC [ADVERSE DRUG REACTION]. CASE DESCRIPTION: REGULATOR-SPONT REPORT (B) (4) RECEIVED ON 01-APR-2010 FROM A PHYSICIAN REGARDING A PT, INITIALS, AGE AND GENDER UNK, WHOSE RELEVANT MEDICAL HISTORY INCLUDED AN ARTHRITIC KNEE. THE PT RECEIVED THE FIRST INJECTION OF SYNVISC, LOT# V0918, INTO THE RIGHT KNEE ON AN UNK DATE. A SEVERE REACTION STARTED ON (B) (6) 2010 FOR WHICH THE PT WAS HOSPITALIZED. CULTURES WERE TAKEN AND WERE NEGATIVE AFTER 48 HRS. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT WAS STILL HOSPITALIZED. NO FURTHER INFO WAS PROVIDED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON 06-APR-2010. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER V0918, EXPIRY DATE 08/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC 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 V0918

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization