MAUDE manufacturer profile

COVIDIEN MFG DC BOULDER · HIH

MAUDE profile for Hysteroscope (And Accessories)

Key facts

Manufacturer COVIDIEN MFG DC BOULDER
Manufacturer group COVIDIEN MFG DC BOULDER
Product code HIH
Product code name Hysteroscope (And Accessories)

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Incorrect Measurement, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Material Fragmentation, No Patient Involvement, Tissue Breakdown, Appropriate Term / Code Not Available 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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