MAUDE manufacturer profile

MEDTRONIC IRELAND · OTD

MAUDE profile for Endovascular Suturing System

Key facts

Manufacturer MEDTRONIC IRELAND
Manufacturer group MEDTRONIC IRELAND
Product code OTD
Product code name Endovascular Suturing System

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Leak/Splash, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Injury, Insufficient Information, Fracture, Malposition of Device 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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