DUROLANE

Additional Manufacturer Narrative

AS REPORTED BY THE PHYSICIAN, AFTER THE INJECTION OF THE DUROLANE PRODUCT INTO THE LEFT HIP WITH SIMULTANEOUS ADMINISTRATION OF AN NSTRIDE APS PROCEDURE, THE PATIENT HAD IMMEDIATE ONSET OF SEVERE PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PER STANDARD PROCEDURE IN CANADA AND RECEIVED MORPHINE FOR PAIN MANAGEMENT. MULTIPLE FOLLOW-UP ATTEMTPS WERE MADE AND LIMITED INFORMATION WAS PROVIDED. THE PHYSICIAN WAS UNABLE TO DISCLOSE ANY COMORBIDITIES OR MEDICATIONS OF THE PATINET. THE PHYSICIAN CONFIRMED THAT NO CULTURES WERE TAKEN AND NO MEDICATIONS WERE PRESCRIBED TO THE PATIENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

Description of Event or Problem

IT WAS REPORTED A PATIENT INJECTED WITH THE DUROLANE PRODUCT EXPERIENCED IMMEDIATE ONSET OF SEVERE PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PER STANDARD PROCEDURE IN CANADA AND RECEIVED MORPHINE FOR PAIN MANAGEMENT. THE PATIENT WAS DIAGNOSED WITH ACUTE SYNOVITIS. THE PATIENT HAD BLOOD DRAWN ON FOUR CONSECTUTIVE DAYS, WITH THE RESULTS SHOWING ELEVATED BLOOD COUNTS THREE TIMES AND RETURNING TO NORMAL LEVELS ON THE FOURTH DRAWN. NO CULTURES WERE TAKEN OF THE AFFECTED AREA, AND NO ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS DISCHARGED AFTER SEVEN DAYS AND HAS A FOLLOW UP APPOINTMENT SCHEDULED WITH THE PHYSICIAN.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A BATCH RECORD REVIEW WAS COMPLETED ON THE LOT NUMBER PROVIDED. THERE WERE NO DEVIATIONS OR ANOMALIES DURING THE MANUFACTURING PROCESS, AND THE PRODUCT MET ALL SPECIFICATIONS PRIOR TO RELEASE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. CORRECTION: B4 INITIAL DATE OF THIS REPORT CORRECTED.