MAUDE manufacturer profile
INNOVATIVE HEALTH, LLC. · PNE
MAUDE profile for Reprocessed Catheter Introducer
Key facts
| Manufacturer | INNOVATIVE HEALTH, LLC. |
|---|---|
| Manufacturer group | INNOVATIVE HEALTH, LLC. |
| Product code | PNE |
| Product code name | Reprocessed Catheter Introducer |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, Leak/Splash, Insufficient Information, Material Separation, Air/Gas in Device, Detachment of Device or Device Component 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