MAUDE manufacturer profile
COVIDIEN (IRVINE) · KRA
MAUDE profile for Catheter, Continuous Flush
Key facts
| Manufacturer | COVIDIEN (IRVINE) |
|---|---|
| Manufacturer group | MICRO THERAPEUTICS, INC. DBA EV3 |
| Product code | KRA |
| Product code name | Catheter, Continuous Flush |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Break, Foreign Body In Patient, Adverse Event Without Identified Device or Use Problem, Difficult to Remove, Device Dislodged or Dislocated, Physical Resistance, Burst Container or Vessel 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