MAUDE manufacturer profile
ETHICON INC. · OTP
MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Key facts
| Manufacturer | ETHICON INC. |
|---|---|
| Manufacturer group | ETHICON SARL-NEUCHATEL |
| Product code | OTP |
| Product code name | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally 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, Migration, Adverse Event Without Identified Device or Use Problem, Not Applicable, Incontinence, Appropriate Term/Code Not Available, No Code Available 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