MAUDE manufacturer profile
COLOPLAST A/S · PWI
MAUDE profile for Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Key facts
| Manufacturer | COLOPLAST A/S |
|---|---|
| Manufacturer group | COLOPLAST MANUFACTURING US, LLC |
| Product code | PWI |
| Product code name | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Foreign Body In Patient, Break, Failure to Disconnect, Blood Loss, Pain, Insufficient Information, Detachment of Device or Device Component 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