MAUDE manufacturer profile

BRACCO INJENEERING S.A. · IZQ

MAUDE profile for Injector, Contrast Medium, Automatic

Key facts

Manufacturer BRACCO INJENEERING S.A.
Manufacturer group ACIST MEDICAL SYSTEMS, INC.
Product code IZQ
Product code name Injector, Contrast Medium, Automatic

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
  • Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Air Embolism, Extravasation, Detachment of Device or Device Component, Break, No Patient Involvement, Insufficient Information 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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