MAUDE manufacturer profile

CARDINAL HEALTH, INC · FCM

MAUDE profile for Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Key facts

Manufacturer CARDINAL HEALTH, INC
Manufacturer group CARDINAL HEALTH
Product code FCM
Product code name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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, Unintended Deflation, Material Rupture, Obstruction of Flow, No Flow, Infusion or Flow Problem, Detachment of Device or Device Component, Fluid/Blood Leak 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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