MAUDE manufacturer profile

BAYLIS MEDICALE CIE INC · DXF

MAUDE profile for Catheter, Septostomy

Key facts

Manufacturer BAYLIS MEDICALE CIE INC
Manufacturer group BOSTON SCIENTIFIC CORPORATION
Product code DXF
Product code name Catheter, Septostomy

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
  • Pericardial Effusion, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Low Blood Pressure/ Hypotension, Cardiac Perforation, Cardiac Tamponade, Material Integrity Problem, Difficult to Advance 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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