MAUDE manufacturer profile

EDWARDS LIFESCIENCES · DQO

MAUDE profile for Catheter, Intravascular, Diagnostic

Key facts

Manufacturer EDWARDS LIFESCIENCES
Manufacturer group EDWARDS LIFESCIENCES PR
Product code DQO
Product code name Catheter, Intravascular, Diagnostic

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
  • No Clinical Signs, Symptoms or Conditions, Material Rupture, No Known Impact Or Consequence To Patient, Inflation Problem, Failure to Deflate, Insufficient Information, Deflation Problem, Break 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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