MAUDE manufacturer profile

EDWARDS LIFESCIENCES DR · KRA

MAUDE profile for Catheter, Continuous Flush

Key facts

Manufacturer EDWARDS LIFESCIENCES DR
Manufacturer group EDWARDS LIFESCIENCES IRVINE
Product code KRA
Product code name Catheter, Continuous Flush

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Hemorrhage/Blood Loss/Bleeding, Break, Appropriate Term/Code Not Available, Mechanical Jam, Incorrect Measurement, Material Separation 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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