MAUDE manufacturer profile
PENUMBRA, INC. · HCG
MAUDE profile for Device, Neurovascular Embolization
Key facts
| Manufacturer | PENUMBRA, INC. |
|---|---|
| Manufacturer group | PENUMBRA, INC. |
| Product code | HCG |
| Product code name | Device, Neurovascular Embolization |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Failure to Advance, No Clinical Signs, Symptoms or Conditions, Physical Resistance/Sticking, Physical Resistance, Premature Separation, Detachment Of Device Component, Material Deformation 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