MAUDE manufacturer profile

TERUMO BCT · LKN

MAUDE profile for Separator, Automated, Blood Cell And Plasma, Therapeutic

Key facts

Manufacturer TERUMO BCT
Manufacturer group TERUMO BCT
Product code LKN
Product code name Separator, Automated, Blood Cell And Plasma, Therapeutic

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Insufficient Information, Inadequate User Interface, No Clinical Signs, Symptoms or Conditions, Data Problem, Improper or Incorrect Procedure or Method, Patient Data 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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