MAUDE manufacturer profile
CONCORD MANUFACTURING · FKX
MAUDE profile for System, Peritoneal, Automatic Delivery
Key facts
| Manufacturer | CONCORD MANUFACTURING |
|---|---|
| Manufacturer group | CONCORD MANUFACTURING |
| 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
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Thermal Decomposition of Device, Peritonitis, Overfill, Abdominal Pain 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