MAUDE manufacturer profile

COVIDIEN LP BARRX · FCG

MAUDE profile for Biopsy Needle

Key facts

Manufacturer COVIDIEN LP BARRX
Manufacturer group COVIDIEN LP BARRX
Product code FCG
Product code name Biopsy Needle

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Hemorrhage/Blood Loss/Bleeding, Pancreatitis, Insufficient Information, Break, Abdominal Pain, Radiation Exposure, Unintended, No Code 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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