MAUDE manufacturer profile
ABBOTT VASCULAR · ORD
MAUDE profile for Optical Coherence Tomography, Intravascular Catheter
Key facts
| Manufacturer | ABBOTT VASCULAR |
|---|---|
| Manufacturer group | ABBOTT VASCULAR |
| Product code | ORD |
| Product code name | Optical Coherence Tomography, Intravascular Catheter |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Poor Quality Image, Material Separation, Contamination /Decontamination Problem, Vasoconstriction, Vascular Dissection, Difficult to Insert 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