MAUDE manufacturer profile
OUTSET MEDICAL, INC. · KDI
MAUDE profile for Dialyzer, High Permeability With Or Without Sealed Dialysate System
Key facts
| Manufacturer | OUTSET MEDICAL, INC. |
|---|---|
| Manufacturer group | OUTSET MEDICAL, INC. |
| Product code | KDI |
| Product code name | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Hemorrhage/Blood Loss/Bleeding, Loss of consciousness, No Clinical Signs, Symptoms or Conditions, Death, Cardiac Arrest, Low Blood Pressure/ Hypotension, Fluid/Blood Leak 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