MAUDE manufacturer profile
ICU MEDICAL COSTA RICA LTD. · FPA
MAUDE profile for Set, Administration, Intravascular
Key facts
| Manufacturer | ICU MEDICAL COSTA RICA LTD. |
|---|---|
| Manufacturer group | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
| Product code | FPA |
| Product code name | Set, Administration, Intravascular |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, No Consequences Or Impact To Patient, No Flow, Chemical Exposure, Crack, Air/Gas in Device, Device Contamination with Chemical or Other Material 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