MAUDE manufacturer profile
SURMODICS, INC. · QEW
MAUDE profile for Peripheral Mechanical Thrombectomy With Aspiration
Key facts
| Manufacturer | SURMODICS, INC. |
|---|---|
| Manufacturer group | SURMODICS, INC. |
| Product code | QEW |
| Product code name | Peripheral Mechanical Thrombectomy With Aspiration |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Fracture, Difficult to Remove, Foreign Body In Patient, Off-Label Use, No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Vascular Dissection, Adverse Event Without Identified Device or Use Problem 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