MAUDE manufacturer profile
MENTOR MEDICAL SYSTEM B.V. · FTR
MAUDE profile for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Key facts
| Manufacturer | MENTOR MEDICAL SYSTEM B.V. |
|---|---|
| Manufacturer group | MENTOR TEXAS |
| Product code | FTR |
| Product code name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Rupture, Capsular Contracture, Adverse Event Without Identified Device or Use Problem, Deformity/ Disfigurement, No Code Available, No Clinical Signs, Symptoms or Conditions, Local Reaction, Granuloma 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