MAUDE manufacturer profile
ALLERGAN (COSTA RICA) · FTR
MAUDE profile for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Key facts
| Manufacturer | ALLERGAN (COSTA RICA) |
|---|---|
| Manufacturer group | ALLERGAN (COSTA RICA) |
| Product code | FTR |
| Product code name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Capsular Contracture, Material Rupture, Failure of Implant, Device Appears to Trigger Rejection, Patient-Device Incompatibility, Seroma, Adverse Event Without Identified Device or Use Problem, Migration 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