BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ

    MDR report key: 2492219 · Received March 12, 2012

    Report

    Report Number
    9612392-2012-00002
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 15, 2012
    Manufacturer
    SEIKAGAKU CORP
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REPORTED TO THE (B)(4) PHARMACOVIGILANCE NETWORK ON (B)(4) 2012. THIS IS A DEFINITIVE REPORT.

    Description of Event or Problem · 1

    ADVERSE EVENT: EFFUSION OF LOWER LEG JOINT. ON (B)(6) 2012, A (B)(6) FEMALE PT RECEIVED 1ST INJECTION OF ARTZ TO THE KNEE FOR GONALGIA. ON (B)(6) 2012, SHE RECEIVED 2ND INJECTION OF ARTZ. ON (B)(6) 2012, SHE RECEIVED 3RD INJECTION OF ARTZ. ON (B)(6) 2012, SHE DEVELOPED EFFUSION IN THE INJECTION SITE DURING INFILTRATION WITH HYALURONIC ACID. SHE WAS ADMINISTERED WITH VOLTAREN (DICLOFENAC), 1 AMPOULE, IM, AND PERFALGAN (PARACETAMOL),1 AMPOULE IV AS SPECIFIC TREATMENT REGARDING THE EVENT. ON (B)(6) 2012, SHE WAS RECOVERING. ACCORDING TO THE REPORTER, THE EVENT CAUSED/PROLONGED HOSPITALIZATION. THE CAUSAL RELATIONSHIP BETWEEN ARTZ AND THE ADVERSE EVENT WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ SODIUM HYALURONATE MOZ SEIKAGAKU CORP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization TORVAST (ATORVASTATIN) - UNK| LOSARTAN (LOSARTAN) - UNK| ATENOLOL (ATENOLOL) - UNK| CARDIOASPIRIN (ACETYLSALICYCLIC ACID) - UNK