MAUDE manufacturer profile
KANEKA CORPORATION · PDI
MAUDE profile for Beta 2-Microglobulin Apheresis Column
Key facts
| Manufacturer | KANEKA CORPORATION |
|---|---|
| Manufacturer group | KANEKA CORPORATION, OSAKA PLANT |
| Product code | PDI |
| Product code name | Beta 2-Microglobulin Apheresis Column |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Low Blood Pressure/ Hypotension, Tachycardia, Loss of consciousness, High Blood Pressure/ Hypertension, Fever, Chest Pain, Vomiting 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