MAUDE manufacturer profile

ST. JUDE MEDICAL · MAE

MAUDE profile for Occluder, Patent Ductus, Arteriosus

Key facts

Manufacturer ST. JUDE MEDICAL
Manufacturer group ST. JUDE MEDICAL
Product code MAE
Product code name Occluder, Patent Ductus, Arteriosus

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Device Dislodged or Dislocated, Material Erosion, Insufficient Information, Malposition of Device, Difficult to Remove, Migration or Expulsion of Device, Migration, Activation, Positioning or Separation 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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