Description of Event or Problem · 1
UPON RECEIPT OF ADDITIONAL INFORMATION ON (B)(4) 2014, THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE EVENT OF "SWELLING OF BOTH KNEES/SWELLING IN THE SITE OF APPLICATION", "PAIN IN BOTH KNEES/ PAIN IN THE SITE OF APPLICATION" AND KNEE EFFUSION WAS UPGRADED TO SERIOUS AS THESE EVENTS REQUIRED INTERVENTION. THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6) 2013 FROM A CONSUMER. BASED ON THE INFORMATION RECEIVED ON (B)(4) 2014, ADDITIONAL EVENTS OF KNEE EFFUSION, SLIGHT DISCOMFORT AND PATELLA PAIN WERE ADDED. BASED UPON ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013, THE EVENTS WERE UPDATED TO PAIN AT INJECTION SITE (PREVIOUSLY REPORTED AS PAIN IN BOTH KNEES) AND SWELLING AT INJECTION SITE (PREVIOUSLY REPORTED AS SWELLING IN BOTH KNEES). THIS CASE CONCERNS A (B)(6) MALE PT WHO EXPERIENCED OF KNEE EFFUSION, SLIGHT DISCOMFORT AND PATELLA PAIN, PAIN AND SWELLING IN THE SITE OF APPLICATION (BOTH KNEES) AFTER RECEIVING SYNVISC ONE INJECTION. NO OTHER RELEVANT MEDICAL HISTORIES, PAST MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. RELEVANT CONCOMITANT MEDICATION INCLUDED ESCITALOPRAM OXALATE (LEXAPRO), CENTRUM AND ROSUVASTATIN FOR CHOLESTEROL (UNSPECIFIED). THE PT REPORTED THAT HE USED TO FEEL KNEE PAIN AFTER PHYSICAL ACTIVITIES. ON AN UNSPECIFIED DATE, AFTER A MAGNETIC RESONANCE IMAGING (MRI) SCAN, THE PHYSICIAN IDENTIFIED ABSENCE OF LIQUID IN THE AREA AND PRESCRIBED SINGLE SYNVISC ONE INJECTION FOR BOTH THE KNEES OF THE PT. ON (B)(6) 2013, THE PT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION (ROUTE OF ADMINISTRATION, DOSAGE REGIMEN, BATCH/LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) INTO BOTH HIS KNEES OR ABSENCE OF LIQUID IN BOTH KNEES. THE PT DID NOT EXPERIENCE ANY PAIN OR SWELLING AFTER THE INJECTION AND FOLLOWED THE RECOMMENDATIONS OF APPLYING ICE ON HIS KNEES. ON (B)(6) 2013, THE PT RAN ON THE TREADMILL FOR 20 MINUTES. ON (B)(6) 2013, 51 DAYS AFTER THE ADMIN OF SYNVISC ONE INJECTION, THE PT STARTED PRESENTING WITH PAIN AND SWELLING IN THE SITE OF APPLICATION. ON AN UNSPECIFIED DATE, THE PT RETURNED TO HIS PHYSICIAN, WHO STATED THAT PAIN WAS DUE TO PT'S PHYSICAL EFFORT. IN (B)(6) 2013, THE PT CONSULTED ANOTHER PHYSICIAN WHO IDENTIFIED THE PT WITH KNEES EFFUSION UPON CHECKING HIS MAGNETIC RESONANCE. THE PT WAS TREATED WITH BETAMETHASONE DIPROPIONATE/BETAMETHASONE SODIUM PHOSPHATE (DIPROSPAN) AND PHYSIOTHERAPY SESSIONS. THE PT WAS REPORTED TO BE OK NOW, WITHOUT PAIN IN BOTH KNEES. SINCE AN UNSPECIFIED DATE, THE PT HAD SLIGHT DISCOMFORT AND PATELLA PAIN. IT WAS REPORTED THAT THE PAIN CEASED COINCIDENTLY WHEN HE STOPPED TAKING ROSUVASTATIN FOR CHOLESTEROL. CORRECTIVE TREATMENT: ICE, BETAMETHASONE DIPROPIONATE/BETAMETHASONE SODIUM PHOSPHATE, PHYSIOTHERAPY SESSIONS FOR "SWELLING OF BOTH KNEES/ SWELLING IN THE SITE OF APPLICATION", "PAIN IN BOTH KNEES/PAIN IN SITE OF APPLICATION" AND KNEE EFFUSION AND UNK FOR SLIGHT DISCOMFORT AND PATELLA PAIN. OUTCOME: RECOVERED/RESOLVED FOR "PAIN IN BOTH KNEES/ PAIN IN SITE OF APPLICATION" NOT RECOVERED/NOT RESOLVED FOR "SWELLING OF BOTH KNEES/ SWELLING OF BOTH KNEES/ SELLING IN THE SITE OF APPLICATION", KNEE EFFUSION, SLIGHT DISCOMFORT AND PATELLA PAIN. SERIOUSNESS: INTERVENTION REQUIRED FOR THE EVENTS OF "SWELLING OF BOTH KNEES/ SWELLING IN THE SITE OF APPLICATION", "PAIN IN BOTH KNEES?PAIN IN SITE OF APPLICATION" AND NEE EFFUSION. A PHARMACEUTICAL TECHNICAL COMPLAINT WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA IS REQUIRED. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE 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 SAFETY. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. THE PT DID NOT ACCEPT THE ASSESMENT OF HIS PRESENT PHYSICIAN AND SCHEDULED AN APPOINTMENT WITH ANOTHER PHYSICIAN. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. THE EVENT TERMS WERE UPDATED TO PAIN IN BOTH KNEES/ PAIN IN SITE OF APPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013. PTC INVESTIGATION REPORT WAS ADDED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 FROM THE CONSUMER. THE CASE WAS UPGRADED FROM NON-SERIOUS TO SERIOUS, ADDITIONAL EVENTS OF KNEE EFFUSION, SLIGHT DISCOMFORT AND PATELLA PAIN WERE ADDED AND CLINICAL COURSE WAS UPDATED. OUTCOME FOR THE EVENT OF "PAIN IN BOTH KNEES/ PAIN IN SITE OF APPLICATION" WAS UPDATED TO RECOVERED. TEXT AMENDED ACCORDINGLY.