BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1427609 · Received July 30, 2009

    Report

    Report Number
    2246315-2009-00136
    Event Type
    Other
    Date Received
    July 30, 2009
    Date of Event
    July 14, 2009
    Report Date
    July 15, 2009
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    SLIGHT HYPERTHERMIA [HYPERTHERMIA]. PAIN [PAIN]. FEELING OF TENSION IN KNEES [SENSATION OF PRESSURE]. COULD NOT WALK [ABASIA]. CALOR [JOINT WARMTH]. SIGNIFICANT SWELLING KNEES [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2009 FROM A (B)(6) FEMALE PT, INITIALS (B)(6). THE PT'S RELEVANT MEDICAL HISTORY INCLUDES SERIOUS BILATERAL KNEE OSTEOARTHRITIS. THE PT RECEIVED HER FIRST DOSE OF SYNVISC ON (B)(6) 2009, ADMINISTERED VIA INTRA-ARTICULAR ROUTE AT A DOSE OF 2 ML, 1X/W PER KNEE. ON (B)(6) 2009, THE PT RECEIVED THE THIRD INJECTION OF SYNVISC IN BOTH KNEES AS PART OF A ROUTINE TREATMENT. IMMEDIATELY AFTER THE THIRD INJECTION, THE PT EXPERIENCED A FEELING OF TENSION IN BOTH KNEES. THE PT HAD PAIN, SWELLING, CALOR AND SLIGHT HYPERTHERMIA. THE FOLLOWING DAY, (B)(6) 2009, THE PT COULD NOT WALK AND THE SWELLING WAS VERY SIGNIFICANT. TREATMENT CONSISTED OF A STEROID, NSAIDS (NON-STEROIDAL ANTI-INFLAMMATORY DRUGS) AND ICE PACK. AS OF (B)(6) 2009, BOTH KNEES SEEM TO AMELIORATE AND THE PT IS ABLE TO WALK AGAIN, ALTHOUGH WITH DIFFICULTY. THE EVENTS WERE REPORTED BY THE PT TO BE OF SEVERE INTENSITY AND NOT YET RECOVERED. CONCOMITANT MEDICATIONS REPORTED INCLUDE ANTIBIOTIC THERAPY (NOT OTHERWISE SPECIFIED). ON (B)(4) 2009, INVESTIGATIONAL SUMMARY WAS RECEIVED. 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 COMPLAINS. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION VISCO SUPPLEMENT MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R