MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · FDF

MAUDE profile for Colonoscope And Accessories, Flexible/Rigid

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC CORK LIMITED
Product code FDF
Product code name Colonoscope And Accessories, Flexible/Rigid

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Burst Container or Vessel, No Consequences Or Impact To Patient, Material Puncture/Hole, Leak/Splash, Use of Device Problem, Inflation Problem, Adverse Event Without Identified Device or Use 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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