MAUDE manufacturer profile

SOMATICS, LLC · GXC

MAUDE profile for Device, Electroconvulsive Therapy

Key facts

Manufacturer SOMATICS, LLC
Manufacturer group SOMATICS, LLC
Product code GXC
Product code name Device, Electroconvulsive Therapy

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Memory Loss/Impairment, Cognitive Changes, No Apparent Adverse Event, Injury, Brain Injury, Insufficient Information, No Clinical Signs, Symptoms or Conditions Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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