BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2103633 · Received May 17, 2011

    Report

    Report Number
    2246315-2011-00117
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    RED [ERYTHEMA], (B)(6), SWELLED [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2011 FROM A PHYSICIAN WHO TREATED THE EVENT, NOT THE ONE WHO INJECTED SYNVISC, REGARDING A PT (INITIALS AND PT IDENTIFIERS NOT PROVIDED) WITH GONARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2011, THE PT INITIATED SYNVISC 2 ML WHICH WAS INJECTED INTO THE KNEE JOINT (LEFT AND/OR RIGHT UNK) AFTER STERILIZING WITH ALCOHOL. THE NEXT DAY, THE KNEE WAS SWOLLEN AND RED. THE PT WENT TO THE HOSPITAL WHERE (B)(6) WAS CONFIRMED AND RESULTED IN THE PT'S HOSPITALIZATION. THE REGION WAS CLEANED. THE PHYSICIAN DID NOT SUSPECT THAT ANY CONTAMINATION EXISTED IN THE SNYNVISC SYRINGE. HE STATED THAT THE WAY OF INJECTED MIGHT NOT BE APPROPRIATE BECAUSE THE PHYSICIAN WHO INJECTED SYNVISC IS NOT A SPECIALIST OF ORTHOPEDIC SURGERY. AS OF (B)(6) 2011, THE PT'S OUTCOME FOR THE EVENT OF (B)(6) WAS NOT YET RECOVERED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS WERE NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF (B)(6) AS DEFINITELY RELATED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE REC'D ON (B)(6) 2011. 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 SPECIFICATIONS 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 AY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    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 UNK Hospitalization