MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · FHW
MAUDE profile for Device, Impotence, Mechanical/Hydraulic
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | FHW |
| Product code name | Device, Impotence, Mechanical/Hydraulic |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Mechanical Problem, No Known Impact Or Consequence To Patient, Inflation Problem, Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem, Material Puncture/Hole, Insufficient Information 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