MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · PNB

MAUDE profile for Biliary Stent System For Benign Strictures

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC CORPORATION
Product code PNB
Product code name Biliary Stent System For Benign Strictures

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Difficult to Remove, Migration, Break, Positioning Problem, Material Deformation, No Code Available 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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