MAUDE brand profile
PENUMBRA SYSTEM ACE68 HIFLOW KIT
MAUDE brand safety profile
Key facts
| Brand name | PENUMBRA SYSTEM ACE68 HIFLOW KIT |
|---|
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Kinked, Aspiration Issue, Physical Resistance, Device Damaged Prior to Use, Retraction Problem, Material Deformation, No Patient Involvement 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