MAUDE manufacturer profile
MEDTRONIC CARDIOVASCULAR SANTA ROSA · OTD
MAUDE profile for Endovascular Suturing System
Key facts
| Manufacturer | MEDTRONIC CARDIOVASCULAR SANTA ROSA |
|---|---|
| Manufacturer group | MEDTRONIC CARDIOVASCULAR SANTA ROSA |
| Product code | OTD |
| Product code name | Endovascular Suturing System |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Injury, Leak/Splash, No Consequences Or Impact To Patient, Death, Device Dislodged or Dislocated, Break, Aneurysm 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