Description of Event or Problem · 1
THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6) 2014 FROM A PHYSICIAN. THIS CASE CONCERNS A MALE PATIENT OF UNKNOWN AGE WHO DEVELOPED KNEE EFFUSION AFTER RECEIVING TREATMENT WITH SYNVISC-ONE INJECTION. NO MEDICAL HISTORY, PAST DRUGS, OTHER CONCOMITANT MEDICATION OR CONCURRENT CONDITIONS WERE REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2014, THE PATIENT RECEIVED TREATMENT WITH INTRAARTICULAR SYNVISC-ONE INJECTION (DOSE, FREQUENCY, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT REPORTED) IN ONE KNEE JOINT (UNSPECIFIED) . AFTER SYNVISC-ONE INJECTION, PATIENT DEVELOPED KNEE EFFUSION. THE PATIENT RECEIVED INTRA-ARTICULAR INJECTION OF TRIAMCINOLONE HEXACETONIDE (HEXATRIONE) FOR THIS EVENT. IT WAS REPORTED THAT OUTCOME WAS SATISFACTORY. ACTION TAKEN: UNKNOWN. OUTCOME: RECOVERED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA WAS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT SAFETY. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER'S SERIOUSNESS ASSESSMENT: KNEE EFFUSION (MEDICALLY SIGNIFICANT) (B)(6) IMPUTABILITY: (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014, BOTH INFORMATION PROCESS TOGETHER WITH THE CLOCK START DATE OF (B)(6) 2014, PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY.