MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · FAE
MAUDE profile for Prosthesis, Penile
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | FAE |
| Product code name | Prosthesis, Penile |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Pain, Erosion, Defective Device, Mechanical Problem 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