MAUDE manufacturer profile
ST. JUDE MEDICAL PUERTO RICO, INC. · KRH
MAUDE profile for Ring, Annuloplasty
Key facts
| Manufacturer | ST. JUDE MEDICAL PUERTO RICO, INC. |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL PUERTO RICO, INC. |
| Product code | KRH |
| Product code name | Ring, Annuloplasty |
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, Backflow, Mitral Regurgitation, Mitral Valve Insufficiency/ Regurgitation, Atrial Fibrillation, Obstruction of Flow, Hemorrhage/Blood Loss/Bleeding, Pleural Effusion 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