BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 8059135 · Received November 12, 2018

    Report

    Report Number
    9610200-2018-00008
    Event Type
    Injury
    Date Received
    November 12, 2018
    Date of Event
    February 20, 2018
    Report Date
    December 7, 2018
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. A PATIENT AFTER THE USE OF THE PRODUCT HYALGAN (INJECTED IN THE SHOULDER WITH AN INTENTIONAL USE FOR UNLABELED INDICATION AND OFF LABEL USE) HAD: PAIN AGGRAVATED. THE CASE WAS INITIALLY DEEMED AS NON-SERIOUS. THE SERIOUSNESS WAS UPGRADED FROM NON-SERIOUS TO SERIOUS FOLLOWING FOLLOW-UP INFORMATION RECEIVED FROM THE RHEUMATOLOGIST. HE CONSIDERED THE EVENT AS SERIOUS DUE TO DISABILITY OR INCAPACITY AND ASSESSED THE CAUSAL RELATIONSHIP BETWEEN HYALGAN AND PAIN AGGRAVATED AS DUBIOUSLY RELATED. THE COMPANY DEEMED THE EVENT AS SERIOUS DUE TO A "MEDICAL IMPORTANT EVENT" AND ASSESSED THE CAUSAL RELATIONSHIP BETWEEN HYALGAN AND PAIN AGGRAVATED AS POSSIBLE CONSIDERING THE CLINICAL STATE OF THE PATIENT DESCRIBED IN THE MEDICAL HISTORY (A CONDITION OF OMARTHROSIS AND ROTATOR CUFF INJURY). THE CASE HAS BEEN DEEMED AS SERIOUS/EXPECTED (ACCORDING TO THE (B)(6) OF HYALGAN 20 MG/2ML, INJECTABLE, AS COVERED BY LABELED TERM PAIN). THE CAUSALITY RELATIONSHIP HAS BEEN EVALUATED AS UNASSESSABLE BY THE COMPANY FOR THE SPECIAL SITUATIONS INTENTIONAL USE FOR UNLABELED INDICATION AND OFF LABEL USE. NO NEW SIGNAL ALERT HAS BEEN DETECTED. NO ADDITIONAL INFORMATION IS REQUIRED TO PERFORM THIS MEDICAL EVALUATION FROM THE PV PHYSICIAN.

    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. A PATIENT AFTER THE USE OF THE PRODUCT HYALGAN (INJECTED IN THE SHOULDER WITH AN INTENTIONAL USE FOR UNLABELED INDICATION AND OFF LABEL USE) HAD: PAIN AGGRAVATED. THE CASE WAS INITIALLY DEEMED AS NON-SERIOUS. THE SERIOUSNESS WAS UPGRADED FROM NON-SERIOUS TO SERIOUS FOLLOWING FOLLOW-UP INFORMATION RECEIVED FROM THE RHEUMATOLOGIST. HE CONSIDERED THE EVENT AS SERIOUS DUE TO DISABILITY OR INCAPACITY AND ASSESSED THE CAUSAL RELATIONSHIP BETWEEN HYALGAN AND PAIN AGGRAVATED AS DUBIOUSLY RELATED. THE COMPANY DEEMED THE EVENT AS SERIOUS DUE TO A "MEDICAL IMPORTANT EVENT" AND ASSESSED THE CAUSAL RELATIONSHIP BETWEEN HYALGAN AND PAIN AGGRAVATED AS POSSIBLE CONSIDERING THE CLINICAL STATE OF THE PATIENT DESCRIBED IN THE MEDICAL HISTORY (A CONDITION OF OMARTHROSIS AND ROTATOR CUFF INJURY). THE CASE HAS BEEN DEEMED AS SERIOUS/EXPECTED (ACCORDING TO THE FRENCH SMPC OF HYALGAN 20 MG/2ML, INJECTABLE, AS COVERED BY LABELED TERM PAIN). THE CAUSALITY RELATIONSHIP HAS BEEN EVALUATED AS UNASSESSABLE BY THE COMPANY FOR THE SPECIAL SITUATIONS INTENTIONAL USE FOR UNLABELED INDICATION AND OFF LABEL USE. FOLLOW-UP ON ((B)(6) 2018): THIS FU HAS BEEN CREATED TO UPLOAD PATIENT'S MEDICAL HISTORY, PATIENT'S INITIAL AND CONCOMITANT MEDICATIONS. THE CASE HAS BEEN DEEMED AS SERIOUS DUE TO PERMANENT IMPAIRMENT, AS THE PHYSICIAN SPECIFIED THAT SINCE THE INJECTION THE PATIENT WAS DISTURBED IN HIS DAILY MOVEMENTS AND NOT IMPROVED BY HIS USUAL TREATMENT. THE CASE HAS BEEN DEEMED AS SERIOUS/UNEXPECTED, CONSIDERING THE PERSISTENCE OF THE PAIN. THE CAUSALITY RELATIONSHIP HAS BEEN EVALUATED AS POSSIBLE BY THE COMPANY, CONSIDERING THE CLINICAL STATE OF THE PATIENT DESCRIBED IN THE MEDICAL HISTORY (A CONDITION OF OMARTHROSIS AND ROTATOR CUFF INJURY). THE CAUSALITY RELATIONSHIP HAS BEEN EVALUATED AS UNASSESSABLE BY THE COMPANY FOR THE SPECIAL SITUATIONS INTENTIONAL USE FOR UNLABELED INDICATION AND OFF LABEL USE. NO NEW SIGNAL ALERT HAS BEEN DETECTED. NO ADDITIONAL INFORMATION IS REQUIRED TO PERFORM THIS MEDICAL EVALUATION FROM THE PV PHYSICIAN.

    Description of Event or Problem · 0

    A (B)(6) ADULT MALE PATIENT (BMI: 32.71 KG/M2) WAS TREATED WITH HYALGAN (SODIUM HYALURONATE) FOR OMARTHROSIS. ON (B)(6) 2018, THE PATIENT RECEIVED AN INJECTION OF ONE VIAL OF HYALGAN (SODIUM HYALURONATE) VIA INTRAARTICULAR ROUTE FOR OMARTHROSIS. IT WAS UNKNOWN WHETHER THE PATIENT HAS ALREADY BEEN TREATED WITH HYALGAN. ON (B)(6) 2018, ABOUT SIX TO NINE HOURS AFTER RECEIVING THE INJECTION, THE PATIENT'S PAIN WORSENED IN THE RIGHT SHOULDER AND RIGHT UPPER LIMB. TO BE NOTED THAT NO PAIN WAS REPORTED RIGHT AFTER THE INJECTION. ON UNSPECIFIED DATE, THE PATIENT CONSULTED THE RHEUMATOLOGIST AGAIN. HYALGAN WAS NOT RESTARTED. THE PATIENT REPORTED HE PLANNED TO CONSULT ANOTHER SURGEON TO TAKE A SECOND OPINION ON (B)(6) 2018. CONCOMITANT TREATMENT INCLUDED: METHYLPREDNISOLONE ACETATE (DEPOMEDROL) AT THE VOLUME OF 2 ML RECEIVED ON (B)(6) 2018, LIDOCAINE (BRAND NAME UNSPECIFIED) AT THE VOLUME OF 2.5 ML AND IODIXANOL (VISIPAQUE 270) AT THE VOLUME OF 1 ML, ALL VIA INTRA-ARTICULAR ROUTE IN THE RIGHT SHOULDER. AT THE TIME OF THE REPORT, THE PATIENT WAS RECOVERING FROM PAIN AGGRAVATED WITH CORRECTIVE TREATMENT WITH LIDOCAINE (VERSATIS 5%), IN RELAY OF FENTANYL (DUROGESIC) WHICH HE HAD BEEN RECEIVING FOR A LONG TIME. TO BE NOTED, CORRECTIVE TREATMENT WAS REPORTED BY THE PATIENT, BUT NOT CONFIRMED BY THE PHYSICIAN. NO MORE INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    A 65-YEAR-OLD ADULT MALE PATIENT (BMI: 32.71 KG/M2) WAS TREATED WITH HYALGAN (SODIUM HYALURONATE) FOR OMARTHROSIS. ON (B)(6) 2018), THE PATIENT RECEIVED AN INJECTION OF ONE VIAL OF HYALGAN (SODIUM HYALURONATE) VIA INTRAARTICULAR ROUTE IN THE RIGHT SHOULDER FOR OMARTHROSIS. THE PATIENT HAD NEVER BEEN TREATED WITH THIS MEDICATION BEFORE. ON THE SAME DAY, ABOUT SIX TO NINE HOURS AFTER RECEIVING THE INJECTION, THE PATIENT'S PAIN WORSENED IN THE RIGHT SHOULDER AND RIGHT UPPER LIMB. TO BE NOTED THAT NO PAIN WAS REPORTED RIGHT AFTER THE INJECTION. ON UNSPECIFIED DATE, THE PATIENT CONSULTED THE RHEUMATOLOGIST AGAIN. THE PATIENT WAS THEN ADDRESSED TO A SHOULDER SPECIALIST SURGEON. THE PATIENT REPORTED HE WAS SUGGESTED TO UNDERGO A SHOULDER PROSTHESIS PLACEMENT DUE TO THE ADVANCED NATURE OF THE ARTHROSIS. HYALGAN WAS NOT RESTARTED. THE PATIENT REPORTED HE PLANNED TO CONSULT ANOTHER SURGEON TO TAKE A SECOND OPINION ON (B)(6) 2018. CONCOMITANT TREATMENT INCLUDED: METHYLPREDNISOLONE ACETATE (DEPOMEDROL) AT THE VOLUME OF 2 ML RECEIVED ON (B)(6) 2018, LIDOCAINE (BRAND NAME UNSPECIFIED) AT THE VOLUME OF 2.5 ML, IODIXANOL (VISIPAQUE 270) AT THE VOLUME OF 1 ML, ALL VIA INTRA-ARTICULAR ROUTE IN THE RIGHT SHOULDER, METFORMIN (GLUCOPHAGE 500), IRBESARTAN (APROVEL 150), ESOMEPRAZOLE (INEXIUM 40), LERCANIDIPINE 10 (BRAND NAME UNSPECIFIED), ALLOPURINOL 100 (BRAND NAME UNSPECIFIED), CETIRIZINE 10 (BRAND NAME UNSPECIFIED), HYDROXYZINE DIHYDROCHLORIDE (ATARAX 25), AND OPIUM/PARACETAMOL (IZALGI 500) FOR PAIN OF OMARTHROSIS (LONG TERM TREATMENT). AT THE TIME OF THE REPORT FROM (B)(6) 2018, THE PATIENT WAS REPORTED AS RECOVERING FROM PAIN AGGRAVATED WITH CORRECTIVE TREATMENT WITH LIDOCAINE (VERSATIS 5%), IN RELAY OF FENTANYL (DUROGESIC) WHICH HE HAD BEEN RECEIVING FOR A LONG TIME. TO BE NOTED, CORRECTIVE TREATMENT WAS REPORTED BY THE PATIENT, BUT NOT CONFIRMED BY THE PHYSICIAN. AT THE TIME OF THE LAST REPORT, THE PAIN WAS STILL PERSISTENT ACCORDING TO THE GENERAL PRACTITIONER, HENCE THE OUTCOME WAS CHANGED TO NOT RECOVERED. THE RHEUMATOLOGIST REPORTED PAIN AGGRAVATED OF THE RIGHT SHOULDER AND RIGHT SUPERIOR LIMB AND CONSIDERED THE EVENT AS SERIOUS DUE TO DISABILITY OR INCAPACITY. HE ASSESSED THE CAUSAL RELATIONSHIP BETWEEN HYALGAN AND PAIN AGGRAVATED AS DUBIOUSLY RELATED. THE GENERAL PRACTITIONER REPORTED AGGRAVATION OF THE RIGHT SHOULDER PAIN AFTER INFILTRATION AND CONSIDERED THE EVENT AS SERIOUS DUE TO PERSISTENT AND SIGNIFICANT DISABILITY, SPECIFYING THAT SINCE THE INJECTION THE PATIENT WAS DISTURBED IN HIS DAILY MOVEMENTS AND NOT IMPROVED BY HIS USUAL TREATMENT WITH IZALGY. SHE CONFIRMED THE MAJORATION OF THE PAIN ONLY INVOLVED THE RIGHT SIDE, WHILE OMARTHROSIS WAS BILATERAL. SHE ASSESSED THE CAUSAL RELATIONSHIP BETWEEN HYALGAN AND PAIN AGGRAVATED AS PROBABLE BUT DID NOT EXCLUDE A ROLE OF THE UNDERLYING OMARTHROSIS ITSELF. TO BE NOTICED THAT THE PATIENT IS RIGHT-HANDER. NO MORE INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902368 HYALGAN HYALURONATE SODIUM MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| S ALLOPURINOL 100 (ALLOPURINOL)| APROVEL 150 (IRBESARTAN)| ATARAX 25 (HYDROXYZINE HYDROCHLORIDE)| CETIRIZINE 10 (CETIRIZINE)| DEPOMEDROL (METHYLPREDNISOLONE ACETATE)| DEPOMEDROL (METHYLPREDNISOLONE ACETATE)| GLUCOPHAGE 500 (METFORMIN HYDROCHLORIDE)| INEXIUM 40 (ESOMEPRAZOLE MAGNESIUM)| IZALGI 500MG/25MG| LERCANIDIPINE 10 (LERCANIDIPINE)| LIDOCAINE (LIDOCAINE)| LIDOCAINE (LIDOCAINE)| VISIPAQUE (IODIXANOL)| VISIPAQUE (IODIXANOL)