MAUDE manufacturer profile
OGDEN MANUFACTURING PLANT · KDI
MAUDE profile for Dialyzer, High Permeability With Or Without Sealed Dialysate System
Key facts
| Manufacturer | OGDEN MANUFACTURING PLANT |
|---|---|
| Manufacturer group | OGDEN MANUFACTURING PLANT |
| Product code | KDI |
| Product code name | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fluid/Blood Leak, Hemorrhage/Blood Loss/Bleeding, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Labelling, Instructions for Use or Training Problem, Hypersensitivity/Allergic reaction, Blood Loss 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