MAUDE manufacturer profile
COVIDIEN (IRVINE) · MFE
MAUDE profile for Agent, Injectable, Embolic
Key facts
| Manufacturer | COVIDIEN (IRVINE) |
|---|---|
| Manufacturer group | MICRO THERAPEUTICS, INC. DBA EV3 |
| Product code | MFE |
| Product code name | Agent, Injectable, Embolic |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Neurological Deficit/Dysfunction, Migration or Expulsion of Device, Foreign Body In Patient, Intracranial Hemorrhage, Infarction, Cerebral, Therapeutic Response, Decreased 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