BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1063065 · Received June 18, 2008

    Report

    Report Number
    2246315-2008-00088
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 30, 2008
    Manufacturer
    GENZYME CORPORATION (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

    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 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.

    Description of Event or Problem · 1

    RIGHT KNEE PAINFUL [ARTHRALGIA]. RIGHT KNEE SWOLLEN [JOINT SWELLING]. FLUID DRAINED FROM RIGHT KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 30-MAY-2008 FROM A (B) (6) FEMALE PT, (B) (6), WHO HAD A RELEVANT MEDICAL HISTORY OF OSTEOARTHRITIS. THE PT RECEIVED A SERIES OF SYNVISC INJECTIONS IN HER RIGHT KNEE. THE 3 INJECTIONS WERE RECEIVED ON THE FOLLOWING DATES: (B) (6) 2008, (B) (6) 2008, AND (B) (6) 2008. HER THIRD INJECTION WAS RECEIVED ON THE MORNING OF (B) (6) 2008, AFTER WHICH SHE TOOK A NAP. WHEN SHE AWOKE FROM HER NAP LATER THAT AFTERNOON, HER RIGHT KNEE WAS VERY PAINFUL AND SWOLLEN. THE PT PLANNED TO CONSULT FURTHER WITH HER PHYSICIAN REGARDING HER SYMPTOMS, WHICH PERSISTED AS OF DATE OF THE REPORT. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS NOT YET RECOVERED. ADD'L INFO WAS RECEIVED ON JUNE 9, 2008 FROM THE PT. SHE UPDATED HER RELEVANT MEDICAL HISTORY TO INCLUDE A BAKER'S CYST AND VARICOSE VEINS IN THE RIGHT LEG. SHE REPORTED THAT SHE WAS STILL EXPERIENCING PAIN AND SWELLING IN THE INJECTED (RIGHT) KNEE. ON (B) (6) 2008, FLUID WAS DRAINED FROM THE RIGHT KNEE. THE FLUID WAS TESTED AND THE TEST RESULTS SHOWED THAT THERE WAS NO INFECTION INVOLVED. THE PHYSICIAN ALSO GAVE HER A CORTISONE SHOT IN THE RIGHT KNEE ON (B) (6) 2008. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS NOT YET RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention