MAUDE manufacturer profile

ACUTUS MEDICAL INC · DYB

MAUDE profile for Introducer, Catheter

Key facts

Manufacturer ACUTUS MEDICAL INC
Manufacturer group ACUTUS MEDICAL INC
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, Low Blood Pressure/ Hypotension, Pericardial Effusion, Cardiac Tamponade, No Clinical Signs, Symptoms or Conditions, Gas/Air Leak, Pulmonary Embolism, Coagulation in Device or Device Ingredient 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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