MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · GEH

MAUDE profile for Unit, Cryosurgical, Accessories

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC CORPORATION
Product code GEH
Product code name Unit, Cryosurgical, Accessories

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Thermal Decomposition of Device, Adverse Event Without Identified Device or Use Problem, Insufficient Heating, Bowel Perforation, Defective Device, Mechanical Problem, Difficult to Remove 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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