MAUDE report

MAUDE report 15311: MCSWAIN DART

Injury · received May 20, 1994 · MEDICAL DYNAMICS, INC.

Key facts

MDR report key 15311
Report number 15311
Event type Injury
Brand name MCSWAIN DART
Catalog number 2050 16 FR
Manufacturer MEDICAL DYNAMICS, INC.
Product code KDQ
Device class Class II
Date received by FDA May 20, 1994
Report date May 18, 1994
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
  • None Death reports for this brand
  • 1–9 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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