BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1582773 · Received January 6, 2010

    Report

    Report Number
    2246315-2010-00001
    Date Received
    January 6, 2010
    Date of Event
    October 27, 2009
    Report Date
    December 29, 2009
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCTION AND QC DOCUMENTATION FOR LOT NUMBER P0905, EXPIRY DATE 01/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    MAJOR INFLAMMATORY REACTION [ARTHRITIS]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: REGULATOR-SPONTANEOUS REPORT RECEIVED ON (B)(6) 2009 FROM A PHYSICIAN, VIA (B)(4), REGARDING A FEMALE PT WHOSE AGE AND INITIALS WERE UNK. THE PT HAD A MEDICAL HISTORY OF GONARTHRITIS. THE PT RECEIVED AN INTRA-ARTICULAR INJECTION OF SYNVISC FROM BATCH P0905201201 USING X-RAY GUIDANCE WITH VISIPAQUE 320 MG. ARTHROGRAPHY CONFIRMED THAT SYNVISC AND VISIPAQUE WERE CORRECTLY INJECTED INTRA-ARTICULARLY. IT WAS NOT REPORTED IF THIS WAS THE PT'S FIRST, SECOND, OR THIRD INJECTION OF SYNVISC. THE PT EXPERIENCED A MAJOR INFLAMMATORY REACTION CHARACTERIZED BY KNEE EFFUSION ON (B)(6) 2009, 48 HOURS FOLLOWING THE SYNVISC INJECTION. AFTER THE OCCURRENCE OF THE EFFUSION, SYNOVIAL FLUID WAS WITHDRAWN AND ANALYZED. LAB TESTS SHOWED SEVERAL LEUKOCYTES, MAINLY EOSINOPHILS. THERE WERE NO MICROCRYSTALS AND THE FLUID WAS STERILE, NO BACTERIA OR FUNGI PRESENT. THE CASE WAS ASSESSED AS SERIOUS (THE SERIOUS CRITERION WAS NOT REPORTED). AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT'S OUTCOME WAS UNK. ADD'L INFO WAS RECEIVED ON (B)(4) 2009 IN THE FORM OF A QA INVESTIGATION SUMMARY. THE PRODUCTION AND QC DOCUMENTATION FOR LOT NUMBER P0905, EXPIRY DATE 01/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. 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 P0905

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other