BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2467731 · Received February 15, 2012

    Report

    Report Number
    2246315-2012-00032
    Event Type
    Other
    Date Received
    February 15, 2012
    Date of Event
    November 2, 2011
    Report Date
    February 9, 2012
    Manufacturer
    GENZYME CORPORATION
    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 RESULTS WERE RECEIVED ON 13-FEB-2012. 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 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

    RECURRENT SWELLING (RIGHT KNEE) [JOINT SWELLING]. THREE POCKETS OF FLUID (KNEE) [JOINT EFFUSION] CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON 09- FEB-2012 FROM A (B)(6) FEMALE PT, INITIALS (B)(6), WITH ARTHRITIS. THE PT¿S MEDICAL HISTORY WAS SIGNIFICANT FOR CORTISONE INJECTION (HAD 6-7 MONTHS OF RELIEF). ON (B)(6) 2011, THE PT INITIATED SYNVISC-ONE (HYLAN G-F) INJECTION, 6ML, ONCE IN THE RIGHT KNEE. ALMOST IMMEDIATELY AFTER RECEIVING THE SYNVISC-ONE INJECTION, THE PT EXPERIENCED RECURRENT SWELLING (RIGHT KNEE). ON AN UNSPECIFIED DATE, IN (B)(6) 2011, THE PT ALSO EXPERIENCED ¿THREE POCKETS OF FLUID (KNEE).¿ THE SYNVISC-ONE LOT NUMBER WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED TREATMENT WITH CORTISONE FOR RECURRENT SWELLING (RIGHT KNEE). ON AN UNSPECIFIED DATE, THE PT WAS TREATED WITH ICE AND MOTRIN (IBUPROFEN) FOR UNK PRODUCT INDICATION. ON AN UNSPECIFIED DATE, AN UNK AMOUNT OF FLUID WAS ASPIRATED. THE SYNVISC-ONE DOES WAS UNCHANGED. THE OUTCOME FOR THE EVENT OF ¿THREE POCKETS OF FLUID (KNEE)¿ WAS NOT PROVIDED. THE EVENT OF RECURRENT SWELLING (RIGHT KNEE) RECOVERED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF RECURRENT SWELLING (RIGHT KNEE) AND ¿THREE POCKETS OF FLUID (KNEE)¿ WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention