MAUDE brand profile

SYSTEM 8 DUAL TRIGGER ROTARY

MAUDE brand safety profile

Key facts

Brand name SYSTEM 8 DUAL TRIGGER ROTARY

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Device Remains Activated, Detachment of Device or Device Component, Fluid/Blood Leak, No Patient Involvement, Fail-Safe Problem, Fail-Safe Did Not Operate, Unintended Power Up 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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