MAUDE report

MAUDE report 64948: SIMON NITINOL FILTER

Injury · received Jan 22, 1997 · NITINOL MEDICAL TECHNOLOGIES, INC.

Key facts

MDR report key 64948
Report number 1222632-1996-00045
Event type Injury
Brand name SIMON NITINOL FILTER
Model number 231A
Catalog number 231A
Manufacturer NITINOL MEDICAL TECHNOLOGIES, INC.
Product code DTK
Device class Class II
Date received by FDA Jan 22, 1997
Report date Dec 26, 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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