MAUDE manufacturer profile
VANTIVE US HEALTHCARE LLC · FKX
MAUDE profile for System, Peritoneal, Automatic Delivery
Key facts
| Manufacturer | VANTIVE US HEALTHCARE LLC |
|---|---|
| Manufacturer group | VANTIVE HEALTHCARE - MOUNTAIN HOME |
| Product code | FKX |
| Product code name | System, Peritoneal, Automatic Delivery |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, Protective Measures Problem, Disconnection, Device Contamination with Chemical or Other Material, Failure to Disconnect, Loose or Intermittent Connection, Material Puncture/Hole 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