MAUDE manufacturer profile

COOK IRELAND LTD · ESW

MAUDE profile for Prosthesis, Esophageal

Key facts

Manufacturer COOK IRELAND LTD
Manufacturer group COOK IRELAND LTD
Product code ESW
Product code name Prosthesis, Esophageal

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Activation, Positioning or Separation Problem, Obstruction/Occlusion, Migration, Improper or Incorrect Procedure or Method, Off-Label Use 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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