MAUDE manufacturer profile
FRESENIUS MEDICAL CARE NORTH AMERICA · FKX
MAUDE profile for System, Peritoneal, Automatic Delivery
Key facts
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
|---|---|
| Manufacturer group | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Product code | FKX |
| Product code name | System, Peritoneal, Automatic Delivery |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Peritonitis, Device Handling Problem, No Known Impact Or Consequence To Patient, Overfill, Death, Hypervolemia, Hernia 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