MAUDE manufacturer profile
CALDERA MEDICAL INC. · OTO
MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Key facts
| Manufacturer | CALDERA MEDICAL INC. |
|---|---|
| Manufacturer group | CALDERA MEDICAL INC. |
| Product code | OTO |
| Product code name | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Erosion, Pain, Unspecified Infection, Adverse Event Without Identified Device or Use Problem, No Information, Patient Device Interaction 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