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Patient 1
THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS REC'D ON (B)(4) 2014 FROM A NON-HEALTHCARE PROFESSIONAL. THIS CASE CONCERNS A FEMALE PATIENT (AGE NOT PROVIDED) WHO HAD COMPLICATED POST PROCEDURAL COURSE, DID NOT FEEL WELL, WAS NON-RESPONSIVE AND DIED FOLLOWING GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO RELEVANT MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2013, THE PATIENT WAS GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER EE01702 AND EE01702A; AND EXPIRATION DATE OF BIOPSY TRANSPORT MEDIA: UNKNOWN; NUMBER OF GRAFTS NOT PROVIDED) ON AN UNSPECIFIED LOCATION FOR THERMAL BURN. ON (B)(6) 2013, THE PATIENT WAS AGAIN GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER EE01702 AND EE01702A AND EXPIRATION DATE: UNKNOWN; NUMBER OF GRAFTS NOT PROVIDED). IT WAS REPORTED THAT THE PATIENT HAD A LONG COMPLICATED COURSE BUT FINALLY RECOVERED AND WENT TO REHABILITATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD GONE HOME AND BEGAN DOING VERY WELL. ON UNKNOWN DATES IN 2013, FEW DAYS AFTER GRAFTING, THE PATIENT DID NOT FEEL WELL FOR FEW DAYS WHEN HER MOTHER FOUND HER UNRESPONSIVE AND WAS UNABLE TO REVIVE HER. ON (B)(6) 2014 (AFTER 10 MONTHS OF GRAFTING), PATIENT DIED OF AN UNKNOWN CAUSE. THE STERILITY AND ENVIRONMENTAL MONITORING RESULTS WERE REC'D. ALL STERILITY RESULTS FOR THE PRODUCTION OF EPICEL LOT EE01702 WERE NEGATIVE FOR CONTAMINATION. ON AN UNKNOWN DATE, THE AUTOPSY WAS PERFORMED WHICH DID NOT ESTABLISH THE CAUSE OF DEATH. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN FOR NON-RESPONSIVE AND NOT BEEN FEELING WELL; RECOVERED FOR COMPLICATED COURSE. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME.