BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3766655 · Received April 11, 2014

    Report

    Report Number
    2246315-2014-45734
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 8, 2014
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2014: IN THIS CASE, THE CAUSAL ROLE OF SYNVISC CANNOT BE EXCLUDED FOR THE OCCURRENCE OF THE EVENT OF INFECTION IN HER LEFT SHOULDER, HOWEVER, THE LACK OF INFO REGARDING THE CONCOMITANT MEDICATIONS USED BY THE PT, THE PAST MEDICAL HISTORY OF THE PT AND THE CONCURRENT CONDITIONS OF THE PT PRECLUDES THE COMPLETE CASE ASSESSMENT.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM UNITED STATES ON (B)(4) 2014 FROM A CONSUMER (PATIENT'S HUSBAND). THIS CASE CONCERNS A PT WHO HAD INFECTION IN HER LEFT SHOULDER (JOINT INFECTION) AFTER RECEIVING TREATMENT WITH SYNVISC INJECTION IN HER LEFT SHOULDER (OFF-LABEL USE). NO MEDICAL HISTORY, PAST DRUGS, OTHER CONCOMITANT MEDICATION OR CONCURRENT CONDITIONS WERE REPORTED. ON AN UNK DATE IN 2014, THE PT INITIATED TREATMENT WITH SYNVISC INJECTION, AT A DOSE OF 02 ML (ROUTE, FREQUENCY, BATCH/LOT NUMBER AND EXPIRATION DATE) INTO HER LEFT SHOULDER (OFF LABEL USE) FOR ARTHRITIS. ON (B)(6) 2014, THE PT RECEIVED THIRD INJECTION OF SYNVISC IN HER LEFT SHOULDER AND COMPLETED THE TREATMENT FOR ARTHRITIS. LATER, THE PT STARTED EXPERIENCING PAIN "AT A 13" ON A 1-10 PAIN SCALE IN HER SHOULDER WITH MILD ARM SWELLING. THE PT DESCRIBED THAT HER ARM WAS CRIMSON IN COLOR AND THAT AN EXTERNAL TEMPERATURE INDICATOR READ 104 (UNITS NOT PROVIDED) ON THE TEMPERATURE READING ON THE SKIN OF HER ARM. ALSO, THE PT COMPLAINED THAT HER LEFT ARM WAS INFLAMED BELOW THE INJECTION SITE DUE TO WHICH ULTRASOUND AND MRI WERE PERFORMED BUT THE RESULTS FOR BOTH WERE UNK AT THE TIME OF REPORT. IT WAS REPORTED THAT THEY VISITED THE TREATING DOCTOR FOUR TIMES AND LATER ON (B)(6) 2014, THE PATIENT WAS ADMITTED INTO THE HOSPITAL. ON AN UNK DATE IN (B)(6) 2014, THE PT UNDERWENT ONE SURGERY ONE WEEK LATER TO CLEAR UP THE INFECTION IN HER SHOULDER. THEN SHE HAD SECOND SURGERY ON HER SHOULDER JOINT AND THE CULTURES WERE PERFORMED WHICH INDICATED THE PRESENCE OF E. COLI. THE PT RECEIVED TWO UNITS OF BLOOD POST HER SURGERIES. THE PT HAD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AND GETTING AN ANTIBIOTIC (UNSPECIFIED AT THE TIME OF REPORT) WHICH PUT HER AT THE RISK FOR GETTING C. DIFFICILE. IT WAS REPORTED THAT THE PT COULD NOT BE DISCHARGED DUE TO THE ONGOING TREATMENT. THE REPORTER WAS CONCERNED ABOUT THE BATCH OF SYNVISC THAT WAS USED FOR PATIENT. ACTION TAKEN: NO ACTION TAKEN. OUTCOME: NOT RECOVERED/NOT RESOLVED. A PHARMACEUTICAL CRITERIA: HOSPITALIZATION AND SURGERY FOR THE EVENT OF "INFECTION IN HER LEFT SHOULDER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221589 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R