MAUDE manufacturer profile

CALDERA MEDICAL INC · HIH

MAUDE profile for Hysteroscope (And Accessories)

Key facts

Manufacturer CALDERA MEDICAL INC
Manufacturer group CALDERA MEDICAL INC
Product code HIH
Product code name Hysteroscope (And Accessories)

At a glance

  • 1–9 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Material Separation, Mechanical Problem, Material Twisted/Bent, Material Deformation, Failure to Power Up 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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