MAUDE brand profile
2008K HEMODIALYSIS SYS OLCDIASAFE PLUS
MAUDE brand safety profile
Key facts
| Brand name | 2008K HEMODIALYSIS SYS OLCDIASAFE PLUS |
|---|
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Device Operates Differently Than Expected, Reflux within Device, Mechanical Problem, Thermal Decomposition of Device, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Death Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1