MAUDE manufacturer profile

KANEKA CORPORETION · PDI

MAUDE profile for Beta 2-Microglobulin Apheresis Column

Key facts

Manufacturer KANEKA CORPORETION
Manufacturer group KANEKA CORPORATION OSAKA PLANT
Product code PDI
Product code name Beta 2-Microglobulin Apheresis Column

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem, Patient-Device Incompatibility, Ischemia, Vertigo, Transient Ischemic Attack, Low Blood Pressure/ Hypotension, No Apparent Adverse Event 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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