MAUDE manufacturer profile
COLOPLAST A/S · FTL
MAUDE profile for Mesh, Surgical, Polymeric
Key facts
| Manufacturer | COLOPLAST A/S |
|---|---|
| Manufacturer group | COLOPLAST MANUFACTURING US, LLC |
| Product code | FTL |
| Product code name | Mesh, Surgical, Polymeric |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1–9 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Pain, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Prolapse, Incontinence, Urinary Tract Infection, Erosion, 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