MAUDE brand profile

OPTIFLUX F160NRE HF 12CS 15SA EBEAM

MAUDE brand safety profile

Key facts

Brand name OPTIFLUX F160NRE HF 12CS 15SA EBEAM

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • Hemorrhage/Blood Loss/Bleeding, Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions, Labelling, Instructions for Use or Training Problem, Hypersensitivity/Allergic reaction, Adverse Event Without Identified Device or Use Problem, Dyspnea, Obstruction of Flow 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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