MAUDE manufacturer profile

ST. JUDE MEDICAL, COSTA RICA LTDA · DYB

MAUDE profile for Introducer, Catheter

Key facts

Manufacturer ST. JUDE MEDICAL, COSTA RICA LTDA
Manufacturer group ST. JUDE MEDICAL, COSTA RICA LTDA
Product code DYB
Product code name Introducer, Catheter

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 Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Fluid/Blood Leak, Cardiac Perforation, Gas/Air Leak, No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, 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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