MAUDE manufacturer profile

COOK INC · MIJ

MAUDE profile for Needle, Tumor Localization

Key facts

Manufacturer COOK INC
Manufacturer group COOK INC.
Product code MIJ
Product code name Needle, Tumor Localization

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
  • Material Separation, No Code Available, Foreign Body In Patient, Break, No Known Impact Or Consequence To Patient, Migration, Fracture, Device Embedded In Tissue or Plaque 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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