BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3185236 · Received June 19, 2013

    Report

    Report Number
    2246315-2013-00362
    Event Type
    Other
    Date Received
    June 19, 2013
    Report Date
    June 11, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. 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: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    KNEE HAD SWELLING, EXPERIENCED MORE SWELLING [JOINT SWELLING]. KNEE WAS DRAINED [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM OTHER NON-HEALTH PROFESSIONAL VIA SALES REP REGARDING A PT (AGE AND GENDER NOT PROVIDED), INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, DOSAGE REGIMEN NOT PROVIDED, IN AN UNSPECIFIED KNEE. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT'S KNEE HAD SWELLING. ON AN UNSPECIFIED DATE, THE PT RECEIVED SECOND INJECTION AND EXPERIENCED MORE SWELLING. ON AN UNSPECIFIED DATE, PT'S KNEE WAS DRAINED (KNEE EFFUSION). THE PT WAS TREATED WITH CORTICOSTEROIDS (UNSPECIFIED) FOR SWELLING IN KNEE AND KNEE EFFUSION. THE ACTION TAKEN WITH SYNVISC WAS NOT PROVIDED. THE OUTCOME FOR BOTH THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND BOTH THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279275 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention