MAUDE manufacturer profile
CRYOLIFE, INC. · OHA
MAUDE profile for Heart Valve, More Than Minimally Manipulated Allograft
Key facts
| Manufacturer | CRYOLIFE, INC. |
|---|---|
| Manufacturer group | CRYOLIFE, INC. |
| Product code | OHA |
| Product code name | Heart Valve, More Than Minimally Manipulated Allograft |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Information, Insufficient Information, Pulmonary Valve Stenosis, Congenital Defect/Deformity, No Code Available, Endocarditis, Obstruction of Flow 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