MAUDE manufacturer profile

ABBOTT MEDICAL · MLV

MAUDE profile for Transcatheter Septal Occluder

Key facts

Manufacturer ABBOTT MEDICAL
Manufacturer group ABBOTT MEDICAL REG# 2135147
Product code MLV
Product code name Transcatheter Septal Occluder

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Difficult to Fold, Unfold or Collapse, Migration or Expulsion of Device, Adverse Event Without Identified Device or Use Problem, Material Deformation, Patient Device Interaction Problem, Off-Label Use, Atrial Fibrillation 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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