MAUDE manufacturer profile
COLOPLAST A/S · OTO
MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Key facts
| Manufacturer | COLOPLAST A/S |
|---|---|
| Manufacturer group | COLOPLAST MANUFACTURING US, LLC |
| 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
- 100–999 Injury reports
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Pain, Adverse Event Without Identified Device or Use Problem, Erosion, Prolapse, Urinary Tract Infection, Urinary Incontinence, Dyspareunia, Abnormal Vaginal Discharge 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