BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 2223124 · Received August 12, 2011

    Report

    Report Number
    2410673-2011-00006
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    950027
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENTS: THIS CASE OF AN ELDERLY MALE IS CONFOUNDED BY THE UNDERLYING HISTORY OF OSTEOARTHRITIS. OF NOTE, THE PT EXPRESSED SATISFACTION AND CONTINUES TO TAKE HYALURONATE SODIUM DESPITE THE REPORTED REACTIONS.

    Description of Event or Problem · 1

    BASED ON ADD'L INFO RECEIVED FROM THE CONSUMER ON 8/5/2011, THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS (BASED ON INITIAL REPORTED EVENT) HAS BEEN UPGRADED TO SERIOUS (BASED ON REPORT OF LUMBAR STENOSIS): THE BELOW NARRATIVE INCLUDES AN INITIAL AND ADD'L INFO RECEIVED FROM A CONSUMER ON (B)(6) 2011 PLUS SUBSEQUENT FOLLOW-UPS: A (B)(6) MALE CONSUMER RECEIVED HYALURONATE SODIUM (HYALGAN) (LOT # AND EXP 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, AN 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 EXP DATE UNK) 3 INJECTIONS EVERY WEEK, FOR OSTEOARTHRITIS, 7 - 8 YEARS AGO. NO FURTHER RELEVANT INFO PROVIDED. ADD'L INFO FOR HYALURONATE SODIUM (LOT # AND EXP DATE UNK) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4) DATED (B)(6) 2011, RECEIVED BY (B)(6) ON (B)(6) 2011: SAMPLE STATUS WAS NOT AVAILABLE. INVESTIGATION WAS ONGOING. CONCLUSION: PENDING. ADD'L INFO FOR HYALURONATE SODIUM (LOT # AND EXP DATE UNK) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4) DATED (B)(6) 2011, RECEIVED BY (B)(6) ON (B)(6) 2011: 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. ADD'L INFO RECEIVED FROM A CONSUMER ON (B)(6) 2011: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT ONSET DATE, ADD'L EVENT, MEDICAL HISTORY, CONCOMITANT MEDICATIONS, DIAGNOSTIC RESULTS, HEIGHT AND WEIGHT WERE PROVIDED. NO FURTHER RELEVANT INFO WAS REPORTED.

    Devices

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

    Patients

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