MAUDE report

MAUDE report 2630: HI FLUX HOLLOW FIBER DIALYZER

Injury · received Mar 10, 1993 · FRESENIUS, USA

Key facts

MDR report key 2630
Report number 2243621-1993-00003
Event type Injury
Brand name HI FLUX HOLLOW FIBER DIALYZER
Model number 01-0080-0
Manufacturer FRESENIUS, USA
Product code KDI
Device class Class II
Date received by FDA Mar 10, 1993
Report date Jan 8, 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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