MAUDE manufacturer profile
CONCORD MANUFACTURING · KDI
MAUDE profile for Dialyzer, High Permeability With Or Without Sealed Dialysate System
Key facts
| Manufacturer | CONCORD MANUFACTURING |
|---|---|
| Manufacturer group | CONCORD MANUFACTURING |
| Product code | KDI |
| Product code name | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Thermal Decomposition of Device, No Patient Involvement, No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, No Known Impact Or Consequence To Patient, Inadequate Ultra Filtration, Melted, Adverse Event Without Identified Device or Use Problem 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