MAUDE report

MAUDE report 6091: HOLLOW FIBER DIALYZER

Injury · received Mar 26, 1993 · TERUMO

Key facts

MDR report key 6091
Report number 2243621-1993-00016
Event type Injury
Brand name HOLLOW FIBER DIALYZER
Model number 01-3115-1
Manufacturer TERUMO
Product code KDI
Device class Class II
Date received by FDA Mar 26, 1993
Report date Jan 13, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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