BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3181364 · Received June 14, 2013

    Report

    Report Number
    2246315-2013-00358
    Date Received
    June 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MFR'S COMMENT: AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.

    Description of Event or Problem · 1

    BLOODY FLUID ASPIRATED FROM RIGHT KNEE [HAEMARTHROSIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN REGARDING A (B)(6) MALE PT, INITIALS (B)(6), WITH OSTEOARTHRITIS OF BOTH KNEES. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) JANUARY 2013, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN GF-20) INJECTION (ROUTE OF ADMIN AND DOSAGE REGIMEN NOT PROVIDED), IN BOTH KNEES. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2013, 20 CC OF BLOODY FLUID WAS ASPIRATED FROM THE RIGHT KNEE (HEMARTHROSIS). THE COMPANY ASSESSED THE EVENT OF "BLOODY FLUID ASPIRATED FROM RIGHT KNEE" AS MEDICALLY SIGNIFICANT. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP OF SYNVISC WITH THE EVENT WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271966 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other