BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2671011 · Received July 23, 2012

    Report

    Report Number
    2246315-2012-00209
    Event Type
    Other
    Date Received
    July 23, 2012
    Report Date
    July 16, 2012
    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 19-JUL-2012. 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 SPECIFICATION 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 THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    KNEE TURNED RED [ERYTHEMA]. KNEE SWELLED [JOINT SWELLING]. KNEE WAS VERY PAINFUL [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON 16-JUL-2012 FROM A PHYSICIAN VIA SALES REPRESENTATIVE REGARDING A FEMALE PATIENT (AGE NOT PROVIDED), INITIALS (B)(6). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G-F 20) INJECTION, DOSAGE REGIMEN NOT PROVIDED, IN AN UNSPECIFIED LOCATION. THE LOT NUMBER FOR SYNVISC ONE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, AFTER SYNVISC ONE INJECTION, THE PATIENT'S KNEE SWELLED, TURNED RED AND WAS VERY PAINFUL. IT WAS REPORTED THAT PATIENT WAS GIVEN STEROID INJECTION BY HEALTH CARE PROFESSIONAL WHICH CALMED HER SYMPTOMS (AFTER CONFIRMING NO INFECTION). THE ACTION TAKEN WITH SYNVISC ONE TREATMENT WAS NOT PROVIDED. THE PATIENT'S OUTCOME FOR ALL THE EVENTS WAS REPORTED AS RECOVERED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC ONE AND THE EVENTS WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC A CID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention