MAUDE manufacturer profile
MICRO THERAPEUTICS, INC. DBA EV3 · KRD
MAUDE profile for Device, Vascular, For Promoting Embolization
Key facts
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
|---|---|
| Manufacturer group | MICRO THERAPEUTICS, INC. DBA EV3 |
| Product code | KRD |
| Product code name | Device, Vascular, For Promoting Embolization |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Separation Failure, Detachment of Device or Device Component, No Known Impact Or Consequence To Patient, Physical Resistance/Sticking, Break, Stretched, Material Deformation 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