MAUDE manufacturer profile

SOMATICS, LLC · QGH

MAUDE profile for Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Key facts

Manufacturer SOMATICS, LLC
Manufacturer group SOMATICS, LLC
Product code QGH
Product code name Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Brain Injury, Memory Loss/Impairment, Suicidal Ideation, Appropriate Term / Code Not Available, Depression, High Blood Pressure/ Hypertension, Convulsion/Seizure, Cognitive Changes 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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