BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3022617 · Received March 22, 2013

    Report

    Report Number
    2246315-2013-00057
    Event Type
    Other
    Date Received
    March 22, 2013
    Report Date
    March 18, 2013
    Manufacturer
    GENZYME CORPORATION
    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 RESULTS WAS REC'D ON (B)(4) 2013. EVALUATION 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 SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATIONS RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATE TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    LEFT KNEE PAIN (ARTHRALGIA). LEFT KNEE SWELLING (JOINT SWELLING). ELEVATED WHITE BLOOD CELL COUNT (WHITE BLOOD CELL COUNT INCREASED). CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2013 FROM A PHYSICIAN VIA SALES REP REGARDING A FEMALE PT IN (B)(6), INITIALS UNK, WITH OSTEOARTHRITIS (MODERATE TO SEVERE). THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF SYNVISC. ON AN UNSPECIFIED DATE, THE PT REC'D TREATMENT WITH SYNVISC ONE INJECTION (HYLAN G-F 20) AT A DOSE OF 6 ML, ONCE IN LEFT KNEE. THE LOT NUMBER OF SYNVISC ONE WAS NOT PROVIDED. NINE HOURS AFTER RECEIVING INJECTION, THE PT EXPERIENCED LEFT KNEE PAIN AND LEFT KNEE SWELLING. TWO WEEKS LATER, THE PT REC'D TREATMENT WITH STEROIDS AS PRESCRIBED BY THE PHYSICIAN AND NO ASPIRATION OF THE KNEE WAS DONE. ON AN UNSPECIFIED DATE LATER, THE PT DEVELOPED WHITE BLOOD CELL COUNT, INCREASED SEDIMENTATION RATE AND ELEVATED ERYTHROCYTE SEDIMENTATION RATE (ESR). THE OUTCOME FOR THE EVENTS OF LEFT KNEE PAIN, LEFT KNEE SWELLING, ELEVATED WHITE BLOOD CELL COUNT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF LEFT KNEE PAIN, LEFT KNEE SWELLING AND ELEVATED WHITE BLOOD CELL COUNT WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSAL RELATIONSHIPS BETWEEN SYNVISC ONE AND THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119781 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention