MAUDE manufacturer profile

STRYKER INSTRUMENTS-KALAMAZOO · GDY

MAUDE profile for Gauze/Sponge, Internal, X-Ray Detectable

Key facts

Manufacturer STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer group STRYKER INSTRUMENTS-KALAMAZOO
Product code GDY
Product code name Gauze/Sponge, Internal, X-Ray Detectable

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Consequences Or Impact To Patient, Material Frayed, No Clinical Signs, Symptoms or Conditions, Detachment Of Device Component, No Known Impact Or Consequence To Patient, Detachment of Device or Device Component, Material Integrity Problem, Delivered as Unsterile Product 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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