MAUDE manufacturer profile

ABBOTT · DYB

MAUDE profile for Introducer, Catheter

Key facts

Manufacturer ABBOTT
Manufacturer group ABBOTT
Product code DYB
Product code name Introducer, Catheter

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Hemorrhage/Blood Loss/Bleeding, Pericardial Effusion, Capturing Problem, Physical Resistance/Sticking, Unintended Movement, Output Problem, Use of Device Problem 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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