FDA Adverse Event
Summary report: N
EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT
MDR report key: 1220333
·
Received November 4, 2008
Report
- Report Number
- 1226230-2008-00016
- Date Received
- November 4, 2008
- Report Date
- October 6, 2008
- Manufacturer
- GENZYME BIOSURGERY (CAMBRIDGE)
- Product Code
- MGR
- PMA / PMN Number
- HDE 990002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT | CULTURED EPIDERMAL AUTOGRAFTS | MGR | GENZYME BIOSURGERY (CAMBRIDGE) | UNK | EE01148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Death| H| O| R |