MAUDE report

MAUDE report 13578: FRESENIUS

Injury · received Apr 18, 1994 · FRESENIUS

Key facts

MDR report key 13578
Report number 2243621-1994-05067
Event type Injury
Brand name FRESENIUS
Model number F-80
Manufacturer FRESENIUS
Product code KOC
Device class Class II
Date received by FDA Apr 18, 1994
Report date Apr 7, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 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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