MAUDE manufacturer profile

UNITED STATES ENDOSCOPY GROUP, INC. · NWU

MAUDE profile for Endoscope Introducer Kit

Key facts

Manufacturer UNITED STATES ENDOSCOPY GROUP, INC.
Manufacturer group UNITED STATES ENDOSCOPY GROUP, INC.
Product code NWU
Product code name Endoscope Introducer Kit

At a glance

  • 1–9 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Entrapment of Device, Detachment of Device or Device Component, Adverse Event Without Identified Device or Use Problem, Rash, Foreign Body In 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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