D
Patient 1
PT EXPERIENCED CHILLS AND NAUSEA APPROX 150 MINUTES AFTER INITIATING HEMODIALYSIS THERAPY. THERAPY WAS PROVIDED WITH A 4TH-USE HEMODIALYZER.
MAUDE MDR 519181
- MDR report key
- 519181
- Report number
- 519181
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-11-05
- Date received
- 2004-03-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASAHI APS HEMODIALYZER | HEMODIALYZER | NEXTRON MEDICAL | FKP | APS-105OS | NA | UNK | N | N | |||
| 2 | RENATRON | REPROCESSING DEVICE | MINNTECH CORP | LIF | RS8330 | NA | UNK | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2004-03-15 | 0 | 1. O |