MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-12 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).
[17199353]
Multi-system organ failure [multi-organ failure]. Case description: spontaneous report was rec'd on (b)(6) 2012 (add'l info on (b)(6) 2012) from a physician regarding a (b)(6) male pt, initials (b)(6) with thermal burn. The pt's medical history was not provided. On (b)(6) 2012, the pt sustained 46 percent tbsa (total body surface area) burns. On (b)(6) 2012, at 16:05 hrs, the left and right groin biopsies were performed. The pt was on two unspecified topical antimicrobial or antifungal medications and two unspecified systemic antimicrobial or antifungal medication. On (b)(6) 2012, the pt was grafted with 96 grafts of epicel (lot# ee01641). On an unspecified date, the pt experienced multisystem organ failure. On (b)(6) 2012, after being grafted with epicel, the pt died due to multisystem organ failure. Concomitant medications were not provided. The intensity for the event of multisystem organ failure was not provided. The physician did not provide the relationship between epicel and the event of multisystem organ failure.
Patient Sequence No: 1, Text Type: D, B5
[17349468]
Mfr's comment: the benefit-risk relationship of epicel is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2012-00006 |
| MDR Report Key | 2791973 |
| Report Source | 05 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-03 |
| Date Mfgr Received | 2012-10-03 |
| Date Added to Maude | 2012-10-17 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | GENZYME BIOSURGERY (CAMBRIDGE) |
| Manufacturer Street | 64 SIDNEY STREET |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02139 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2012-10-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | EE01641 |
| ID Number | UNK |
| Device Expiration Date | 2012-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-10-12 |