BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2023220 · Received February 15, 2011

    Report

    Report Number
    2246315-2011-00044
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 7, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, ADD'L INFO WAS RECEIVED IN THE FORM OF QA RESULTS WITHOUT A LOT NUMBER. 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 CONFORMANCE TO SPECS PRIOR TO RELEASE. ANY OUT OF SPEC RESULT IS IDENTIFIED AND MITIGATED THROUGH THE (B)(4) 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. MFR'S COMMENT: THE BENEFIT RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Description of Event or Problem · 1

    ARTHRITIS [ARTHRITIS], PYREXIA [PYREXIA], RASH [RASH]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM THE HCP OF A (B)(6) MALE PT WITH A HISTORY OF OSTEOARTHRITIS OF THE KNEE, RENAL CANCER, AND DIABETES MELLITUS, INITIALS S-T, WHO EXPERIENCED ARTHRITIS, PYREXIA, AND RASH AFTER STARTING SYNVISC. THE PT RECEIVED THE FIRST SYNVISC INJECTION ON (B)(6) 2011 (EXACT KNEE NOT PROVIDED). ON (B)(6) 2011, THE PT DEVELOPED ARTHRITIS, PYREXIA, AND RASH AND WAS HOSPITALIZED. THE HCP DID NOT PROVIDE THE SEVERITY OF THE EVENTS. IN THE OPINION OF THE HCP, ALL THE EVENTS ARE "POSSIBLY" RELATED TO THE USE OF SYNVISC IN THE PT. ACCORDING TO THE HCP, AT THE TIME OF THIS REPORT, THE PT HAD RECOVERED FROM THE EVENTS OF ARTHRITIS AND PYREXIA. AS OF (B)(6) 2011, THE EVENT OF RASH WAS STILL ONGOING.

    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 65 YR Hospitalization