MAUDE report

MAUDE report 2352: PERCU SHEATH INTRO KIT

Death · received Jan 29, 1993 · ARROW INTERNATIONAL, INC.

Key facts

MDR report key 2352
Report number 2352
Event type Death
Brand name PERCU SHEATH INTRO KIT
Model number AK 09810
Catalog number AK09810
Manufacturer ARROW INTERNATIONAL, INC.
Product code DSP
Device class Class II
Date received by FDA Jan 29, 1993
Report date Dec 30, 1992
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
  • 1–9 Death reports for this brand
  • None 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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