D
Patient 1
PATIENT EXPIRED FOLLOWING SURGERY TO THE SKULL. REPORTER STATED THAT THE EVENT DID NOT APPEAR TO BE RELATED TO THE USE OF THE PRODUCT.
MAUDE MDR 344167
- MDR report key
- 344167
- Report number
- 1225520-2001-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-01-01
- Date received
- 2001-07-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KEVIN JOHNSON MANAGER
- Address
- 40 GRISSOM RD. SUITE 100 PLYMOUTH MA 02360 US
- Phone
- 508-508-5087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYMPHONY PC SYSTEM | CENTRIFUGE (BLOOD PROCESSING) | HARVEST TECHNOLOGIES | JQC | 276040000 | SMP1000 | NA | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-07-28 | 0 | 1. O |