MAUDE manufacturer profile

PHILIPS VOLCANO · OBJ

MAUDE profile for Catheter, Ultrasound, Intravascular

Key facts

Manufacturer PHILIPS VOLCANO
Manufacturer group VOLCARICA S.R.L.
Product code OBJ
Product code name Catheter, Ultrasound, Intravascular

At a glance

  • 100–999 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 Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Entrapment of Device, Foreign Body In Patient, Adverse Event Without Identified Device or Use Problem, No Display/Image, Material Protrusion/Extrusion 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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