MAUDE manufacturer profile

MICRO THERAPEUTICS, INC. DBA EV3 · MJN

MAUDE profile for Catheter, Intravascular Occluding, Temporary

Key facts

Manufacturer MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer group MICRO THERAPEUTICS, INC. DBA EV3
Product code MJN
Product code name Catheter, Intravascular Occluding, Temporary

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Burst Container or Vessel, Inflation Problem, Adverse Event Without Identified Device or Use Problem, Leak/Splash, No Known Impact Or Consequence To Patient, Intracranial Hemorrhage, Rupture 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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