MAUDE brand profile

LEKSELL GAMMAPLAN

MAUDE brand safety profile

Key facts

Brand name LEKSELL GAMMAPLAN

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • Improper or Incorrect Procedure or Method, Unintended Radiation Exposure, Application Program Problem, Computer Software Problem, Adverse Event Without Identified Device or Use Problem, Use of Incorrect Control/Treatment Settings, Brain Injury, 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

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