MAUDE manufacturer profile
COSTA RICA · FWM
MAUDE profile for Prosthesis, Breast, Inflatable, Internal, Saline
Key facts
| Manufacturer | COSTA RICA |
|---|---|
| Manufacturer group | COSTA RICA |
| Product code | FWM |
| Product code name | Prosthesis, Breast, Inflatable, Internal, Saline |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Failure of Implant, Fluid/Blood Leak, Capsular Contracture, Device Appears to Trigger Rejection, Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available, Lymphoma, Material Rupture 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