MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · ODG

MAUDE profile for Endoscopic Ultrasound System, Gastroenterology-Urology

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC CORPORATION
Product code ODG
Product code name Endoscopic Ultrasound System, Gastroenterology-Urology

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Detachment of Device or Device Component, No Consequences Or Impact To Patient, Mechanical Problem, Appropriate Term/Code Not Available, Inflammation, Device Contamination with Chemical or Other Material 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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