BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3010341 · Received March 14, 2013

    Report

    Report Number
    2246315-2013-00050
    Event Type
    Other
    Date Received
    March 14, 2013
    Report Date
    March 8, 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 WERE RECEIVED ON (B)(4) 2013. 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 SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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. 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

    INFECTION NOS [INFECTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM AN OFFICE STAFF VIA A SALES REP REGARDING A FEMALE PT (DEMOGRAPHICS NOT PROVIDED), INITIALS UNKNOWN. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE (APPROX 2-3 YEARS AGO), THE PT INITIATED TREATMENT WITH SERIES OF SYNVISC (HYLAN G-F 20) INJECTION, ROUTE OF ADMINISTRATION AND DOSAGE REGIMEN NOT PROVIDED, IN AN UNSPECIFIED LOCATION. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED INFECTION (UNSPECIFIED) WHICH RESULTED IN EMERGENCY SURGERY. ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF INFECTION (UNSPECIFIED) WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENT WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108546 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention