MAUDE manufacturer profile
UNOMEDICAL UM-D · FPA
MAUDE profile for Set, Administration, Intravascular
Key facts
| Manufacturer | UNOMEDICAL UM-D |
|---|---|
| Manufacturer group | UNOMEDICAL UM-D |
| Product code | FPA |
| Product code name | Set, Administration, Intravascular |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Twisted/Bent, No Clinical Signs, Symptoms or Conditions, Hyperglycemia, Elevated ketones/Diabetic Ketoacidosis, Infusion or Flow Problem, Detachment of Device or Device Component, Adverse Event Without Identified Device or Use Problem, Leak/Splash 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