MAUDE manufacturer profile
MENTOR WORLDWIDE LLC · FTR
MAUDE profile for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Key facts
| Manufacturer | MENTOR WORLDWIDE LLC |
|---|---|
| Manufacturer group | MENTOR TEXAS |
| Product code | FTR |
| Product code name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Pain, Fatigue, Adverse Event Without Identified Device or Use Problem, Patient-Device Incompatibility, Arthralgia, Anxiety, Hair Loss, Headache 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