MAUDE manufacturer profile
MICRO THERAPEUTICS, INC. DBA EV3 · FTL
MAUDE profile for Mesh, Surgical, Polymeric
Key facts
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
|---|---|
| Manufacturer group | SOFRADIM PRODUCTION SAS |
| Product code | FTL |
| Product code name | Mesh, Surgical, Polymeric |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Mechanics Altered, Adverse Event Without Identified Device or Use Problem, Erectile Dysfunction, Nodule, Emotional Changes, Scar Tissue, Hernia, Unspecified Tissue Injury 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