MAUDE manufacturer profile

STRYKER SUSTAINABILITY SOLUTIONS PHOENIX · OWQ

MAUDE profile for Reprocessed Intravascular Ultrasound Catheter

Key facts

Manufacturer STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
Manufacturer group STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
Product code OWQ
Product code name Reprocessed Intravascular Ultrasound Catheter

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Poor Quality Image, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Use of Device Problem, No Clinical Signs, Symptoms or Conditions, Device Operates Differently Than Expected, Pericardial Effusion, Image Display Error/Artifact 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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