MAUDE manufacturer profile
BIOSPHERE MEDICAL, S.A. · HCG
MAUDE profile for Device, Neurovascular Embolization
Key facts
| Manufacturer | BIOSPHERE MEDICAL, S.A. |
|---|---|
| Manufacturer group | BIOSPHERE MEDICAL, S.A. |
| Product code | HCG |
| Product code name | Device, Neurovascular Embolization |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Fever, Foreign Body Reaction, Embolism, Patient Problem/Medical Problem, Pain, Occlusion 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