MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-17 for EPICEL manufactured by Genzyme Biosurgery (cambridge).
[5225689]
This unsolicited device case from the united states was received on 11/10/2014 from a physician. This case involved a patient (demographics not provided) who experienced suspected multi-system organ failure after grafted with epicel cultured epidermal autografts (epicel). The patient's past drugs, medical history, concomitant medications or concurrent conditions were not reported. On (b)(6) 2014, the patient was grafted with epicel cultured epidermal autografts, once ((dose, formulation, route, indication, expiration date: not reported and batch/lot number - ee01845). It was reported that the patient was grafted with 48 grafts. On (b)(6) 2014, the patient was grafted for a second time with 48 grafts of epical culture epidermal autografts. On an unknown date, the patient experienced suspected multi-system organ failure. On (b)(6) 2014, the patient expired after being grafted twice with epicel cultured epidermal autografts. It was reported that patient passed away due to suspected multi-system organ failure. Action take: unknown. Corrective treatment: unknown. Outcome: fatal. A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) and results were pending for the same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2014-57057 |
| MDR Report Key | 4264537 |
| Report Source | 05 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-11-10 |
| Date Mfgr Received | 2014-11-10 |
| Date Added to Maude | 2014-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTEN SHARMA, MD |
| Manufacturer Street | 55 CORPORATE DRIVE MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089812784 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2014-11-17 |
| Lot Number | EE01845 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Address | CAMBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-11-17 |