MAUDE manufacturer profile
FRESENIUS MEDICAL CARE NORTH AMERICA · KDI
MAUDE profile for Dialyzer, High Permeability With Or Without Sealed Dialysate System
Key facts
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
|---|---|
| Manufacturer group | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Product code | KDI |
| Product code name | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Device Operates Differently Than Expected, Mechanical Problem, Reflux within Device, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Death, Cardiac Arrest 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