MAUDE manufacturer profile
ABBOTT MEDICAL · KRH
MAUDE profile for Ring, Annuloplasty
Key facts
| Manufacturer | ABBOTT MEDICAL |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612 |
| Product code | KRH |
| Product code name | Ring, Annuloplasty |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Lack of Effect, Mitral Valve Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions, Atrial Fibrillation, Heart Block, Stroke/CVA, Hemorrhage/Blood Loss/Bleeding 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