MAUDE manufacturer profile

ABBOTT MEDICAL · LWQ

MAUDE profile for Heart-Valve, Mechanical

Key facts

Manufacturer ABBOTT MEDICAL
Manufacturer group ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612
Product code LWQ
Product code name Heart-Valve, Mechanical

At a glance

  • 1,000+ 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, Adverse Event Without Identified Device or Use Problem, Physical Resistance/Sticking, Incomplete Coaptation, Insufficient Information, Hemorrhage/Blood Loss/Bleeding, Fracture, Patient Device Interaction 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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