MAUDE manufacturer profile
ETHICON INC. · OTO
MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Key facts
| Manufacturer | ETHICON INC. |
|---|---|
| Manufacturer group | ETHICON INC. - SAN LORENZO PR |
| Product code | OTO |
| Product code name | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Erosion, Pain, Other (for use when an appropriate device code cannot be identified), Adverse Event Without Identified Device or Use Problem, Other (for use when an appropriate patient code cannot be identified), No Code Available, Migration, Migration or Expulsion of Device 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