BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2011761 · Received March 7, 2011

    Report

    Report Number
    2246315-2011-00038
    Event Type
    Other
    Date Received
    March 7, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 1, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# W1016, WITH EXPIRATION DATE 08/2013 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    COULD NOT WAKE UP FOR THREE DAYS (B)(6); PAIN IN BOTH KNEES [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM A HEALTH CARE PROVIDER, REGARDING AN (B)(6) FEMALE PT, INITIALS (B)(6). THE PT HAD A HISTORY OF GONARTHROSIS AND HYPERTENSION. THE PT EXPERIENCED PAIN IN BOTH KNEES AND WAS NOT ABLE TO WAKE UP FOR THREE DAYS AFTER RECEIVING SYNVISC. ON (B)(6) 2011, THE PT RECEIVED THE FIRST SYNVISC INJECTION INTO BOTH KNEES. ON (B)(6) 2011, PAIN DEVELOPED IN BOTH KNEES, FOR WHICH SHE COULD NOT WAKE UP FOR THREE DAYS. SYNVISC WAS PERMANENTLY STOPPED ON (B)(6) 2011. THE PT DID NOT RETURN TO THE CLINIC FOR HER SECOND INJECTION. ON (B)(6) 2011, THE PAIN WAS STILL PRESENT, BUT THE PT COULD WALK. THE REPORTING PHYSICIAN ASSESSED THE EVENTS AS SERIOUS AND DEFINITELY RELATED TO SYNVISC. THE HCP REPORTED THE PT'S EVENTS LED TO PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY. THE PT'S CONCOMITANT THERAPY INCLUDED OLMESARTAN MEDOXOMIL ((B)(6) 2007 - CONTINUING, HYPERTENSION) AND AMLODIPINE BESILATE ((B)(6) 2007 - CONTINUING, HYPERTENSION). AT THE TIME OF THIS REPORT, THE PT WAS NOT YET RECOVERED. THE LOT NUMBER WAS REPORTED TO BE W1016. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 IN THE FORM OF QA RESULTS. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# W1016, WITH EXPIRATION DATE 08/2013 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    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 W1016

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Disability AMLODIPINE BESILATE (DATE OF TX (B)(6)-ONGOING)| OLMESARTAN MEDOXOMIL (DATE OF TX (B)(6)-ONGOING)