MAUDE manufacturer profile

COVIDIEN MFG DC BOULDER · LFL

MAUDE profile for Instrument, Ultrasonic Surgical

Key facts

Manufacturer COVIDIEN MFG DC BOULDER
Manufacturer group COVIDIEN MFG DC BOULDER
Product code LFL
Product code name Instrument, Ultrasonic Surgical

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
  • Detachment of Device or Device Component, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Failure to Fire, Detachment Of Device Component, Intermittent Energy Output, Break, Adverse Event Without Identified Device or Use Problem 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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