MAUDE report

MAUDE report 15317: FRESENIUS

Injury · received Dec 27, 1993 · FRESENIUS USA, INC.

Key facts

MDR report key 15317
Report number 2243621-1993-00206
Event type Injury
Brand name FRESENIUS
Model number F60
Catalog number 0155002
Manufacturer FRESENIUS USA, INC.
Product code KDI
Device class Class II
Date received by FDA Dec 27, 1993
Report date Aug 28, 1993
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
  • 10–99 Death reports for this brand
  • 100–999 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:

Browse all MAUDE medical device reports