MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · PKL

MAUDE profile for Hemostatic Metal Clip For The Gi Tract

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC CORPORATION
Product code PKL
Product code name Hemostatic Metal Clip For The Gi Tract

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Activation, Positioning or Separation Problem, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Premature Activation, Adverse Event Without Identified Device or Use Problem, Break, Difficult to Open or Close, No Known Impact Or Consequence To Patient 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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