MAUDE manufacturer profile
KORU MEDICAL SYSTEMS · FPA
MAUDE profile for Set, Administration, Intravascular
Key facts
| Manufacturer | KORU MEDICAL SYSTEMS |
|---|---|
| Manufacturer group | KORU MEDICAL SYSTEMS |
| Product code | FPA |
| Product code name | Set, Administration, Intravascular |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Insufficient Information, Fail-Safe Did Not Operate, Contamination /Decontamination Problem, Needle Stick/Puncture, Leak/Splash, Diaphoresis, Material Separation 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