EPICEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2015-04-01 for EPICEL manufactured by .

Event Text Entries

[5660929] Expired [death]. Case description: this spontaneous device case from united states was received on (b)(6) 2015 from a healthcare professional. This case concerns a patient of unknown age and sex who expired after grafting with 96 sheets of epicel cultured epidermal autografts (epicel). No medical history, past drugs, concurrent conditions, concomitant medication were reported. On (b)(6) 2015, the patient was grafted with 96 sheets of epicel grafts batch/lot number ee01865. On (b)(6) 2015, patient expired. Further details including description of clinical presentation, signs, symptoms, diagnostic tests, baseline data, diagnosis, cause of death and autopsy results were not reported. Pre-release sterility test results from (b)(6) 2015 to (b)(6) 2015 were negative. Final product sterility test result from (b)(6) 2015 to (b)(6) 2015 was negative. Environmental results were positive for personnel monitoring of manufacturing for grade a, b and personnel monitoring of qc sterility grade. Outcome: fatal. Seriousness criterion: death. The reporter did not provide the causal relationship between the event and epicel grafts. The company considers the event to be related to epicel at this point due to insufficient information being available about the cause of death and co-morbid conditions. Additional follow up was received on (b)(6) 2015 in the form of sterility results which were negative.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1226230-2015-00001
• MDR Report Key: 4712355
• Report Source: 00,05
• Date Received: 2015-04-01
• Date of Report: 2015-03-03
• Date of Event: 2015-02-28
• Date Mfgr Received: 2015-03-03
• Date Added to Maude: 2015-04-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 64 SIDNEY ST.
• Manufacturer City: CAMBRIDGE MA 02139
• Manufacturer Country: US
• Manufacturer Postal: 02139
• Manufacturer G1: AASTROM BIOSCIENCES INC.
• Manufacturer Street: DOMINO'S FARMS, LOBBY K 24 FRANK LLOYD WRIGHT DR
• Manufacturer City: ANN ARBOR MI 48105
• Manufacturer Country: US
• Manufacturer Postal Code: 48105
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EPICEL
• Generic Name: NONE
• Product Code: OCE
• Date Received: 2015-04-01
• Lot Number: EE01865
• ID Number: 50099796
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2015-04-01