MAUDE manufacturer profile

THERAKOS INC. · LNR

MAUDE profile for System, Photopheresis, Extracorporeal

Key facts

Manufacturer THERAKOS INC.
Manufacturer group MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Product code LNR
Product code name System, Photopheresis, Extracorporeal

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Fluid/Blood Leak, Leak/Splash, Device Displays Incorrect Message, Break, Blood Loss, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use 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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