MAUDE brand profile

8FR ANGIOSEAL STS PLUS OUS

MAUDE brand safety profile

Key facts

Brand name 8FR ANGIOSEAL STS PLUS OUS

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Patient Involvement, No Consequences Or Impact To Patient, Activation, Positioning or Separation Problem, Detachment of Device or Device Component, Blood Loss, Detachment Of Device Component, Kinked, Device Damaged Prior to Use 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

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