MAUDE brand profile
2008KHOME HEMODIALYSIS SYSTEM W BIBAG
MAUDE brand safety profile
Key facts
| Brand name | 2008KHOME HEMODIALYSIS SYSTEM W BIBAG |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Fluid/Blood Leak, Mechanical Problem, Reflux within Device, Adverse Event Without Identified Device or Use Problem, Death, No Clinical Signs, Symptoms or Conditions, Inadequate Ultra Filtration 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