BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2660776 · Received July 10, 2012

    Report

    Report Number
    2246315-2012-00195
    Date Received
    July 10, 2012
    Report Date
    July 2, 2012
    Manufacturer
    GENZYME BIOSURGERY
    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

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4)-2012. 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 THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY/SAFETY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    SWELLING [SWELLING]. PYREXIA [PYREXIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)-2012 FROM A PHYSICIAN REGARDING A FEMALE PT, INITIALS (B)(6) (DEMOGRAPHICS NOT PROVIDED). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION (DOSE REGIMEN NOT PROVIDED). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT DEVELOPED SWELLING AND PYREXIA. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT RECOVERED FROM BOTH THE EVENTS. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND BOTH THE EVENTS AS PROBABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other