MAUDE manufacturer profile

ICU MEDICAL INC · FPA

MAUDE profile for Set, Administration, Intravascular

Key facts

Manufacturer ICU MEDICAL INC
Manufacturer group ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
Product code FPA
Product code name Set, Administration, Intravascular

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Leak/Splash, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Fluid/Blood Leak, Insufficient Information, Obstruction of Flow, Disconnection 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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