Description of Event or Problem · 1
INFECTIOUS INFLAMMATION [INFECTION]. INFECTIOUS INFLAMMATION [INFLAMMATION]. PUNCTURED A YELLOW FLUID EXTRAVASATED [EXTRAVASATION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 12/22/2010, FROM A HEALTHCARE PROVIDER, VIA A COMPANY REP, REGARDING A PATIENT. THE PATIENT HAD AN UNKNOWN HISTORY. ON UNSPECIFIED DATES, THE PATIENT RECEIVED THREE SYNVISC INJECTIONS INTO AN UNKNOWN LOCATION. THE HCP REPORTED, THE PATIENT HAD AN INFECTIOUS INFLAMMATION DURING THE LAST TWO WEEKS AFTER THE THIRD SYNVISC INJECTION, WHEN PUNCTURED A YELLOW EXTRAVASATED. THE SYNVISC THERAPY WAS STOPPED PERMANENTLY. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. PLEASE (B)(4) FOR OTHER EVENTS FROM THIS REPORTER. ADDITIONAL INFORMATION WAS RECEIVED ON 12/23/2010 IN THE FORM OF QA RESULTS. THE PRODUCT LOT NUMBER WAS NOT PROVIDED THEREFORE; A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINTS. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.