MAUDE manufacturer profile
OGDEN MANUFACTURING PLANT · FJI
MAUDE profile for Dialyzer, Capillary, Hollow Fiber
Key facts
| Manufacturer | OGDEN MANUFACTURING PLANT |
|---|---|
| Manufacturer group | OGDEN MANUFACTURING PLANT |
| Product code | FJI |
| Product code name | Dialyzer, Capillary, Hollow Fiber |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fluid/Blood Leak, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Blood Loss, No Clinical Signs, Symptoms or Conditions, Occlusion Within Device, Hypersensitivity/Allergic reaction, Hemorrhage/Blood Loss/Bleeding 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