BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 6063075 · Received October 28, 2016

    Report

    Report Number
    9610200-2016-00011
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 3, 2016
    Report Date
    October 28, 2016
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011017 ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) IS SUBMITTING THIS REPORT EVEN ON BEHALF OF FIDIA PHARMA USA INC. (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. FIDIA HAS BEEN INFORMED FOR THIS CASE THROUGH THE PARTNER, THAT IT IS THE MAH IN THIS TERRITORY. ACCORDING TO THE (B)(4) OF HYALGAN KNEE PAIN (INJECTION SITE JOINT PAIN), INJECTION SITE JOINT SWELLING AND EFFUSION OF KNEE (INJECTION SITE JOINT EFFUSION) ARE LISTED, WHEREAS INCREASED C-REACTIVE PROTEIN AND INCREASED ERYTHROCYTE SEDIMENTATION RATE ARE UNLISTED. THE REPORTING PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY. HOWEVER, AS THIS IS A SPONTANEOUS CASE REPORT, CAUSALITY IS CONSIDERED IMPLIED. PHARMACOLOGICAL RELATIONSHIP IS PLAUSIBLE. NO RISK FACTORS OR CONCOMITANT DRUGS WERE REPORTED. DUE TO A GIVEN TEMPORAL RELATIONSHIP A RELATIONSHIP TO HYALGAN CANNOT BE EXCLUDED AND THE CAUSALITY IS ASSESSED AS PROBABLE. THE BENEFIT/RISK PROFILE OF THE PRODUCT REMAINS UNCHANGED. DEVICE WAS NOT AVAILABLE.

    Description of Event or Problem · 0

    (B)(6) YEAR-OLD FEMALE PATIENT DEVELOPED KNEE PAIN, SWELLING, EFFUSION, AS WELL AS INCREASE OF C-REACTIVE PROTEIN (CRP) AND ERYTHROCYTES SEDIMENTATION RATE FOLLOWING TREATMENT WITH HYALGAN (HYALURONIC ACID). THE PATIENT, SUFFERING FROM OSTEOARTHRITIS(OA), RECEIVED THREE HYALGAN INJECTIONS INTO THE RIGHT KNEE FOR GONARTHROSIS (1ST ON (B)(6) 2016, 2ND ON (B)(6) 2016, 3RD ON (B)(6) 2016). AFTER THE 4TH INJECTION ADMINISTERED ON (B)(6) 2016, THE PATIENT DEVELOPED HEAVY PAIN AND KNEE SWELLING ON (B)(6) 2016. ON (B)(6) 2016 HEAVY PAIN STARTED AND SHE WENT TO THE HOSPITAL AMBULANCE AND STARTED ANTIBIOTIC TREATMENT WITH AMOXICOMP ORALLY. ON (B)(6) 2016, THE PATIENT HAD ANOTHER CONTROL VISIT IN THE AMBULANCE, WHERE A SIGNIFICANT JOINT EFFUSION WITHOUT HYPERTHERMIA OF THE KNEE WAS DIAGNOSED. DURING FURTHER CONTROL VISIT IN THE AMBULANCE ON (B)(6) 2016 , IT WAS DECIDED TO TREAT THE PATIENT STATIONARY, BECAUSE THE SITUATION HAS WORSENED. DURING THE STATIONARY PERIOD IN HOSPITAL, SHE RECEIVED INFUSIONS WITH RINGER + 2 G KEFZOL (CEFAZOLIN). PAIN MEDICATION WAS TAKEN ORALLY (VOLTAREN CAPSULES). FROM (B)(6) 2016, SHE WAS TREATED IN HOSPITAL. LABORATORY PARAMETER SHOWED AN INCREASE OF CREACTIVE PROTEIN (CRP) AND ERYTHROCYTES SEDIMENTATION RATE. SMEAR WAS NEGATIVE (NO BACTERIAL INFECTION). THE PATIENT RECOVERED COMPLETELY FROM THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716356 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization