BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1469694 · Received September 10, 2009

    Report

    Report Number
    2246315-2009-00167
    Event Type
    Other
    Date Received
    September 10, 2009
    Date of Event
    August 27, 2009
    Report Date
    September 1, 2009
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # R0907. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER X0804, EXPIRY DATE 10/2011 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER R0907, EXPIRY DATE 03/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    FLUID IN BOTH KNEE [JOINT EFFUSION]. SWELLING IN BOTH KNEES [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(4) 2009 FROM A PHYSICIAN REGARDING A (B)(6) MALE PT, INITIALS UNK, WHOSE RELEVANT MEDICAL HISTORY INCLUDED: ARTHRITIS AND GOUT. THE PT RECEIVED 3 SYNVISC INJECTIONS INTO BOTH KNEES, WITH EACH INJECTION RECEIVED IN EACH KNEE ON THE FOLLOWING DATES: (B)(6) 2009. THE PHYSICIAN PROVIDED 2 DIFFERENT SYNVISC LOT NUMBERS FOR THE PT: X0804 AND R0907 WITH EXPIRATION DATES IN 2011. STARTING ON (B)(6) 2009, THE PT EXPERIENCED SWELLING IN BOTH KNEES. THE PHYSICIAN REMOVED 50CC OF FLUID FROM BOTH KNEES AND EVALUATION OF THE FLUID REVEALED NO CRYSTALS. THE PT WAS TREATED WITH AN INTRAMUSCULAR STEROID INJECTION AND A MEDROL DOSE-PACK AND STARTED ON KEFLEX. THE PHYSICIAN BELIEVED THAT THE SWELLING HAD RESOLVED, BUT PLANNED TO SEE THE PT ON (B)(6) 2009. NO FURTHER INFO WAS PROVIDED. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE OVERALL PT OUTCOME WAS UNK. THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARIES WERE RECEIVED ON (B)(4) 2009. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER X0804, EXPIRY DATE 10/2011 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER R0907, EXPIRY DATE 03/2012 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 UNK X0804

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention