MAUDE manufacturer profile
ASTORA WOMEN'S HEALTH LLC · OTP
MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Key facts
| Manufacturer | ASTORA WOMEN'S HEALTH LLC |
|---|---|
| Manufacturer group | ASTORA WOMEN'S HEALTH LLC |
| Product code | OTP |
| Product code name | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Pain, Adverse Event Without Identified Device or Use Problem, Death, Insufficient Information, Incontinence, Urinary Tract Infection, Erosion, Prolapse 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