MAUDE manufacturer profile

HAPPIEST BABY · QTG

MAUDE profile for Infant Supine Sleep System

Key facts

Manufacturer HAPPIEST BABY
Manufacturer group HAPPIEST BABY
Product code QTG
Product code name Infant Supine Sleep System

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Apparent Adverse Event, Insufficient Information, Product Quality Problem, Protective Measures Problem, Unexpected Shutdown, Defective Component, Material Integrity Problem 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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