BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1172642 · Received September 11, 2008

    Report

    Report Number
    2246315-2008-00139
    Event Type
    Other
    Date Received
    September 11, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 28, 2008
    Manufacturer
    GENZYME BIOSURGERY ( RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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.

    Description of Event or Problem · 1

    RIGHT KNEE EFFUSION [JOINT EFFUSION]. PAIN IN BOTH KNEES [ARTHRALGIA]. SWELLING BOTH KNEES [JOINT SWELLING]. SWELLING OF LOWER LEGS AND FEET [OEDEMA PERIPHERAL]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B) (6) 2008 FROM A (B) (6) FEMALE CONSUMER WITH A HISTORY OF TORN MENISCUS, TORN MENISCUS SURGERY AND ARTHRITIS, (B) (6), WHO EXPERIENCED PAIN IN BOTH KNEES, SWELLING IN BOTH KNEES, SWELLING OF LOWER LEGS AND FEET AND RIGHT KNEE EFFUSION AFTER STARTING SYNVISC. THE PATIENT RECEIVED INJECTIONS OF SYNVISC IN BOTH KNEES ON (B) (6) 2008, (B) (6) 2008 AND (B) (6) 2008. THE PATIENT EXPERIENCED SWELLING AND PAIN IN BOTH KNEES BEGINNING THE DAY AFTER THE THIRD SYNVISC INJECTION. ON (B) (6) 2008, THE PHYSICIAN REMOVED 60ML OF FLUID FROM THE PATIENT'S RIGHT KNEE AND WRAPPED BOTH KNEES VERY TIGHT. THE PATIENT'S LOWER LEGS AND FEET BEGAN SWELLING. ON (B) (6) 2008, THE KNEE WRAPS WERE REMOVED FROM BOTH KNEES AND THE RIGHT KNEE BEGAN TO SWELL AGAIN. THE PATIENT WAS PRESCRIBED IBUPROFEN. THE SWELLING AND PAIN IN HER LEFT KNEE RESOLVED ON (B) (6) 2008. ON THAT DATE, THE PATIENT WAS EXAMINED BY HER PRIMARY CARE PHYSICIAN, WHO ADMINISTERED AN STEROID INJECTION INTO HER RIGHT KNEE. THE PATIENT'S RIGHT KNEE REMAINED SWOLLEN AND PAINFUL. THE PATIENT FELT THE KNEE PAIN WAS DUE TO THE SWELLING. THE PATIENT WAS SCHEDULED TO SEE HER PRIMARY CARE PHYSICIAN ON (B) (6) 2008 TO HAVE HER RIGHT KNEE DRAINED AND ANOTHER STEROID INJECTION. AT THE TIME OF THIS REPORT, THE OUTCOME WAS UNKNOWN.

    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 ( RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R