MAUDE manufacturer profile

A PLUS · GDY

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

Key facts

Manufacturer A PLUS
Manufacturer group ROI CPS, LLC
Product code GDY
Product code name Gauze/Sponge, Internal, X-Ray Detectable

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Material Frayed, No Clinical Signs, Symptoms or Conditions, Material Integrity Problem, Insufficient Information, No Consequences Or Impact To Patient, Foreign Body In Patient, Defective Component 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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