Description of Event or Problem · 1
ENTEROBACTERIAL INFECTION [BACTERIAL INFECTION]. GRAFTS LOST [SKIN GRAFT FAILURE]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 06/05/2008 FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE PT WHO HAD A RELEVANT MEDICAL HISTORY OF A THERMAL BURN. THE PT RECEIVED HER FIRST GRAFTING OF EPICEL CEA (CULTURED EPIDERMAL AUTOGRAFTS; LOT # EE01141-22) ON APPROX THREE MONTHS EARLIER. OF THE 72 GRAFTS RECEIVED, THE INITIAL TAKE WAS 40% BUT A WEEK LATER IT WAS 0% TAKE AS ALL GRAFTS WERE LOST. SHE RECEIVED HER SECOND GRAFTING (LOT # EE01141-31) ON THE FOLLOWING MONTH. OF THE 48 GRAFTS RECEIVED, THERE WAS 0% TAKE. SHE RECEIVED HER THIRD GRAFTING (LOT # EE01141-32) ON A MONTH LATER. OF THE 72 GRAFTS RECEIVED, THERE WAS 0% TAKE. SHE RECEIVED HER FOURTH GRAFTING (LOT # EE01141-33) ON FOUR DAYS LATER. OF THE 48 GRAFTS RECEIVED, THERE WAS 0% TAKE. THE REPORTER STATED THAT THE SURGEON ATTRIBUTED THE POOR TAKE TO AN ENTEROBACTERIAL INFECTION. THE PATIENT'S BIOPSY REPORT WAS OBTAINED ON 06/05/2008. ON FOUR MONTHS EARLIER, THE PT WAS BURNED OVER 80% OF HER TOTAL BODY SURFACE AREA (TBSA); 70% TBSA FULL THICKNESS, 10% TBSA PARTIAL THICKNESS. ON THAT DAY, THE PT WAS ADMITTED TO THE HOSPITAL'S BURN CARE AND RECONSTRUCTIVE CENTER. SHE WAS BIOPSIED ON TWO DAYS LATER AT 12:30. THE BIOPSY SITE OF TUBE 1 WAS THE RIGHT AXILLA AND THE BIOPSY SITE OF TUBE 2 WAS THE LEFT AXILLA (EXPIRATION DATE ON TUBES: 04/30/2008). AT THE TIME OF THE BIOPSY, THE PT DID NOT HAVE ANY WOUND INFECTIONS OR SYSTEMIC INFECTIONS. THE ONLY CURRENT MEDICATION REPORTED WAS SILVADENE. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS UNKNOWN. ADDITIONAL INFO WAS RECEIVED ON 06/05/2008 FROM A COMPANY REPRESENTATIVE. AN INTERNET REPORT STATED THAT THE A WOMAN WHO SUFFERED BURNS OVER MOST OF HER BODY FROM AN ASSAULT IN THE SAME MONTH, DIED AT THE HOSPITAL AROUND 1:45 AM ON TWO MONTHS LATER. ACCORDING TO THE REPORT, THE DOCTORS REPORTED THAT INFECTIONS DUE TO THE PATIENT'S BURNS LED TO HER DEATH. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS FATAL ON THE SAME DAY.