MAUDE manufacturer profile
ROCHE DIAGNOSTICS · FPA
MAUDE profile for Set, Administration, Intravascular
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | UNOMEDICAL DEVICES S.A DE C.V |
| Product code | FPA |
| Product code name | Set, Administration, Intravascular |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Leak/Splash, No Consequences Or Impact To Patient, Hyperglycemia, No Known Impact Or Consequence To Patient, Material Separation, Connection Problem, Elevated ketones/Diabetic Ketoacidosis, Adverse Event Without Identified Device or Use Problem 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