MAUDE report

MAUDE report 37801: FUSA F8 (HF/PS/1.8/M)

Injury · received Aug 30, 1996 · FUSA

Key facts

MDR report key 37801
Report number 54354-1996-00275
Event type Injury
Brand name FUSA F8 (HF/PS/1.8/M)
Model number *
Catalog number 0159087
Manufacturer FUSA
Product code KDI
Device class Class II
Date received by FDA Aug 30, 1996
Report date Aug 27, 1996
Report source Maude

At a glance

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