MAUDE manufacturer profile

MICRO THERAPEUTICS, INC. DBA EV3 · MFE

MAUDE profile for Agent, Injectable, Embolic

Key facts

Manufacturer MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer group MICRO THERAPEUTICS, INC. DBA EV3
Product code MFE
Product code name Agent, Injectable, Embolic

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Foreign Body In Patient, Intracranial Hemorrhage, Detachment of Device or Device Component, Migration or Expulsion of Device, Hemorrhage/Blood Loss/Bleeding, Entrapment of Device 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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