MAUDE manufacturer profile

MICRO THERAPEUTICS, INC. DBA EV3 · HCG

MAUDE profile for Device, Neurovascular Embolization

Key facts

Manufacturer MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer group MICRO THERAPEUTICS, INC. DBA EV3
Product code HCG
Product code name Device, Neurovascular Embolization

At a glance

  • 100–999 MAUDE reports
  • 10–99 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, No Clinical Signs, Symptoms or Conditions, Separation Failure, Intracranial Hemorrhage, Thrombosis/Thrombus, Stroke/CVA, No Known Impact Or Consequence To Patient, Hemorrhage/Blood Loss/Bleeding 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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