MAUDE manufacturer profile
KANEKA CORPORATION · LOX
MAUDE profile for Catheters, Transluminal Coronary Angioplasty, Percutaneous
Key facts
| Manufacturer | KANEKA CORPORATION |
|---|---|
| Manufacturer group | KANEKA CORPORATION OSAKA PLANT |
| Product code | LOX |
| Product code name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Rupture, Fracture, Vascular Dissection, Foreign Body In Patient, Material Separation, Device Embedded In Tissue or Plaque, No Known Impact Or Consequence To Patient, Material Fragmentation 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