BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3132628 · Received May 24, 2013

    Report

    Report Number
    2246315-2013-00332
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    March 9, 2013
    Report Date
    May 21, 2013
    Manufacturer
    GENZYME BIOSURGERY (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

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WAS REC'D ON (B)(4) 2013. 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 SPECIFICATIONS RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATE TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MFR'S COMMENT: AS ONLY LIMITED INFO HAS BEEN OBTAINED SO FAR, IT IS DIFFICULT TO ASSESS A CAUSE AND EFFECT RELATIONSHIP.

    Description of Event or Problem · 1

    DEATH NOS (DEATH). ADVERSE EVENT NOS (ADVERSE EVENT). CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2013 FROM A NON-HEALTH PROFESSIONAL REGARDING A (B)(6) MALE PT INITIALS (B)(6) WITH OSTEOARTHROSIS OF LEFT LEG. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, THE PT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G-F 20) AT A DOSE OF 6ML, ONCE IN LEFT KNEE (ROUTE NOT PROVIDED). THE LOT NUMBER FOR SYNVISC ONE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT WAS HOSPITALIZED FOR AN UNREPORTED CAUSE (ADVERSE EVENT NOS). ON (B)(6) 2013, THE PT EXPIRED DUE TO AN UNREPORTED CAUSE (DEATH NOS). RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE UNK ADVERSE EVENT WAS NOT PROVIDED AND FOR THE EVENT OF DEATH WAS SEVERE. THE CAUSAL RELATIONSHIP BETWEEN SYNVISC ONE AND BOTH THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232202 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H