MAUDE manufacturer profile
NIPRO CORPORATION (ODT) · KDI
MAUDE profile for Dialyzer, High Permeability With Or Without Sealed Dialysate System
Key facts
| Manufacturer | NIPRO CORPORATION (ODT) |
|---|---|
| Manufacturer group | NIPRO CORPORATION (ODT) |
| Product code | KDI |
| Product code name | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions, Patient-Device Incompatibility, Adverse Event Without Identified Device or Use Problem, Hemorrhage/Blood Loss/Bleeding, Dyspnea, Low Blood Pressure/ Hypotension, Abdominal Pain Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1