MAUDE manufacturer profile

ABBOTT MEDICAL · MAE

MAUDE profile for Occluder, Patent Ductus, Arteriosus

Key facts

Manufacturer ABBOTT MEDICAL
Manufacturer group ABBOTT MEDICAL
Product code MAE
Product code name Occluder, Patent Ductus, Arteriosus

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Migration or Expulsion of Device, Difficult to Fold, Unfold or Collapse, Adverse Event Without Identified Device or Use Problem, Obstruction/Occlusion, Patient Device Interaction Problem, Off-Label Use, Improper or Incorrect Procedure or Method 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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