MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-11-05 for EPICEL manufactured by Genzyme Biosurgery (cambridge).
[3941692]
This serious unsolicited device case from united states received on (b)(4) 2013 from a non-healthcare professional. This case concerns a pt (demographics unk) who died after grafting with epicel cultured epidermal autografts (epicel). The pt's medical history, past drug, concomitant medication or concurrent condition was not reported. On (b)(6) 2013, the pt was grafted with 110 grafts of epicel cultured epidermal autografts (batch/lot number ee01736 and expiration date unk) on an unspecified location for thermal burn. On (b)(6) 2013 (35 days following grafting with epicel cultured epidermal autografts), the pt died due to an unreported cause. No corrective treatment was reported. Outcome: fatal. A pharmaceutical technical complaint (ptc) was initiated with global ptc number of (b)(4) and conclusion was pending for the same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2013-10660 |
| MDR Report Key | 3466880 |
| Report Source | 04,07 |
| Date Received | 2013-11-05 |
| Date of Report | 2013-10-28 |
| Date of Event | 2013-10-28 |
| Date Mfgr Received | 2013-10-28 |
| Date Added to Maude | 2013-11-14 |
| 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 Street | 55 CORPORATE DR. MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089816698 |
| 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 | 2013-11-05 |
| Lot Number | EE01736 |
| Operator | OTHER |
| Device Age | DA |
| 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 | 2013-11-05 |