[146475820]
This spontaneous report was received from a company representative on (b)(6) 2019, concerning a (b)(6) year-old female patient, who experienced fatal organ failure for an unspecified period of time after being grafted with cultured epidermal autografts (epicel) with lot number ee02285. The patient was grafted four times: (b)(6) 2018 (96 units), (b)(6) 2018 (96 units), (b)(6) 2018 (96 units), (b)(6) 2018 (48 units), (b)(6) 2018 (96 units). The relevant medical history and concomitant medication details were not reported. On (b)(6) 2018, at 11:56 am the biopsy was harvested. On an unspecified date, the patient experienced organ failure after being treated with epicel. Further details including a description of clinical presentations, signs, symptoms, diagnostic tests, and baseline data and diagnosis were not provided. On (b)(6) 2019, after 161 days of the fifth grafting, the patient expired due to organ failure. The qc sterility test was performed and results of pre-release sample type (b)(4) was passed and sterility test results of final product sample type (b)(4) was also reported as passed. Environmental results included personal monitoring of manufacturing which had passed with grade a and grade b parameters and personnel monitoring of qc sterility which had also passed with grade a parameters. The quality control assay was reviewed which included (b)(4) graft inspection assay, (b)(4) dual stain assay, and (b)(4) endotoxin assay, all were reported as passed. The outcome of the event of organ failure was fatal on (b)(6) 2019, 161 days after the last epicel graft and 445 days after the first epicel graft. The autopsy results were not provided. The causal relationship of the event of organ failure to epicel was not provided by the reporting physician. The company assessed the events of organ failure as related to epicel. This report qualified for 30-day report as the event contributed to the death of the patient.
Patient Sequence No: 1, Text Type: D, B5