BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 2243946 · Received August 26, 2011

    Report

    Report Number
    9610200-2011-00009
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 25, 2011
    Manufacturer
    FIDIA FARMACEUTICI S.P.A
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS HAS BEEN UPGRADED BY SANOFI-AVENTIS TO SERIOUS BASED ON THE REPORT OF SLIGHT LUMBAR STENOSIS. IT IS FIDIA'S OPINION THAT THIS CASE DOES NOT FULFILL ANY SERIOUSNESS CRITERIA. MOREOVER, THE INFORMATION AVAILABLE AT THE TIME BEING DOES NOT REASONABLY SUGGEST THAT HYALGAN MAY HAVE CAUSED OR CONTRIBUTED TO THE LUMBAR STENOSIS. OF NOTE, THE PT EXPRESSED SATISFACTION AND CONTINUES TO TAKE HYALURONATE SODIUM DESPITE THE REPORTED ADVERSE EVENT. FIDIA IS REPORTING THIS CASE TO THE AGENCY MERELY FOR COMPLETENESS SAKE.

    Description of Event or Problem · 1

    FIDIA RECEIVED THIS INFORMATION FROM SANOFI-AVENTIS, THE U.S. DISTRIBUTOR FOR HYALGAN (REFERENCE NO. (B)(4)). BASED ON ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER ON 05-AUG-2011, THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS (BASED ON INITIAL REPORTED EVENT) HAS BEEN UPGRADED BY SANOFI-AVENTIS TO SERIOUS (BASED ON REPORT OF LUMBAR STENOSIS): THE BELOW NARRATIVE INCLUDES AN INITIAL AND ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER ON (B)(6) 2011 PLUS SUBSEQUENT FOLLOW-UPS: A (B)(6) MALE CONSUMER RECEIVED HYALURONATE SODIUM (HYALGAN) (LOT # AND EXPIRATION DATE UNK) ON (B)(6) 2010 AND (B)(6) 2011. ON (B)(6) 2010 HE "FLEW OFF THE TABLE" AFTER HIS RIGHT KNEE INJECTION EVEN WITH THE USE OF LIDOCAINE SPRAY. HE WAS IN PAIN FOR 3-5 DAYS AND WAS TOLD TO PUT ICE ON IT AND IT WENT AWAY. HE CONTINUED TO FEEL SLIGHT PAIN IN THE INJECTION AREA. HE ALSO REPORTED INJECTION SITE PAIN IN HIS KNEE AFTER THE (B)(6) 2010 INJECTION. IN (B)(6) 2011, HE BEGAN TO GET A RADIATING PAIN BEGINNING IN THE INJECTION AREA ON HIS RIGHT KNEE. THE PAIN BECAME WORSE AND RADIATED FROM HIS OUTSIDE RIGHT KNEE DOWN TO HIS FOOT AND UP INTO HIS LEG AND BACK OF HIPS. IT HAPPENED SPORADICALLY AND WAS NOT A "BONE ON BONE PAIN." MRI ON (B)(6) 2011 (SITE UNK) SHOWED NO SIGNIFICANT CHANGES TO BONE ON BONE. ON (B)(6) 2011, AND EMG WAS DONE WHICH SHOWED SLIGHT NERVE DAMAGE AT L5. FURTHER TESTING WITH A MRI OF LUMBAR SPINE ON (B)(6) 2011 SHOWED SLIGHT LUMBAR STENOSIS AT L-5. THERAPY WITH HYALURONATE SODIUM WAS ON GOING AT THE TIME OF REPORT. HE REPORTED THAT HYALGAN IS WORKING WELL FOR HIM AND HE CONTINUES TO TAKE IT. CONCOMITANT MEDICATION INCLUDED LISINOPRIL AND HYDROCHLOROTHIAZIDE. HE HAD NO KNOWN ALLERGIES. MEDICAL HISTORY INCLUDED BONE ON BONE OSTEOARTHRITIS BI-LATERAL. HE ALSO USED SYNVISC IN THE PAST. HE ALSO RECEIVED HYALURONATE SODIUM (HYALGAN) (LOT # AND EXPIRATION DATE UNK) 3 INJECTIONS EVERY WEEK, FOR OSTEOARTHRITIS, 7-8 YEARS AGO. NO FURTHER RELEVANT INFORMATION PROVIDED. ADDITIONAL INFORMATION FOR HYALURONATE SODIUM (LOT # AND EXPIRATION DATE UNK) FROM (B)(4): SAMPLE STATUS WAS NOT AVAILABLE. INVESTIGATION WAS ON GOING. CONCLUSION: PENDING. ADDITIONAL INFORMATION FOR HYALURONATE SODIUM (LOT # AND EXPIRATION DATE UNK) FROM (B)(4): NO BATCH NUMBER WAS RECEIVED ON THIS COMPLAINT; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED. THIS COMPLAINT WILL BE CLOSED. IF BATCH NUMBER IS RECEIVED, THIS COMPLAINT WILL BE REOPENED AND RESPONDED TO ACCORDINGLY. CASE STATUS: CLOSED. ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER ON (B)(6) 2011: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT ONSET DATE, ADDITIONAL EVENT, MEDICAL HISTORY, CONCOMITANT MEDICATIONS, DIAGNOSTIC RESULTS, HEIGHT AND WEIGHT WERE PROVIDED. NO FURTHER RELEVANT INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other HYDROCHLOROTHIAZIDE(CO)| LISINOPRIL(CON.)