MAUDE report

MAUDE report 22608: DIALYZER

Injury · received Jun 5, 1995 · FRESENIUS USA, INC.

Key facts

MDR report key 22608
Report number 2243621-1995-05116
Event type Injury
Brand name DIALYZER
Model number 0100800
Manufacturer FRESENIUS USA, INC.
Product code FJI
Device class Class II
Date received by FDA Jun 5, 1995
Report date Jun 1, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 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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