Description of Event or Problem · 1
THIS SERIOUS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(4) ON (B)(6) 2013 FROM A PHYSICIAN (TRANSPLANT SPECIALIST) VIA OUR (B)(4). THIS CASE CONCERNS A PT (DEMOGRAPHICS UNK) WHO EXPERIENCED SEPSIS AFTER SEPRAFILM PLACEMENT. NO RELEVANT MEDICAL HISTORY, PAST DRUGS, OTHER CONCOMITANT MEDICATION OR CONCURRENT CONDITIONS WERE REPORTED. ON AN UNSPECIFIED DATE, SEPRAFILM WAS PLACED DURING AN UNSPECIFIED PROCEDURE (NUMBER OF SHEETS, BATCH/LOT NUMBER UNK AND EXPIRATION DATE UNK) INTO AN UNSPECIFIED ANATOMICAL LOCATION FOR UNK INDICATION. LATER, ON AN UNSPECIFIED DATE (AFTER UNK LATENCY), THE PT EXPERIENCED SEPSIS. ON AN UNK DATE, THE PT DIED DUE TO SEPSIS. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: FATAL. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4) AND CONCLUSION WAS PENDING FOR THE SAME. SEPSIS (SEPSIS). REPORTING PHYSICIAN'S SERIOUSNESS ASSESSMENT: SERIOUS (DEATH). REPORTING PHYSICIAN'S ASSESSMENT: NOT RELATED. PHARMACOVIGILANCE COMMENT: SANOFI COMMENT DATED (B)(6) 2013: IN THIS CASE THE CAUSAL ROLE OF SEPRAFILM CANNOT BE EXCLUDED FOR THE OCCURRENCE OF SEPSIS, HOWEVER THERE IS NO INFO REGARDING THE UNDERLYING MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS USED BY THE PT PRECLUDES THE COMPLETE CASE ASSESSMENT, AND MOREOVER THE LACK OF INFO REGARDING THE AUTOPSY FINDINGS OF THE PT PRECLUDES THE COMPLETE CASE ASSESSMENT.