MAUDE manufacturer profile

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION · OEZ

MAUDE profile for Cardiovascular Procedure Kit

Key facts

Manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer group SAME
Product code OEZ
Product code name Cardiovascular Procedure Kit

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Blood Loss, Disconnection, Fluid/Blood Leak, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Leak/Splash, No Clinical Signs, Symptoms or Conditions, Connection Problem 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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