MAUDE report

MAUDE report 39512: ACCUSTICK INTRODUCER SYSTEM

Injury · received Sep 19, 1996 · MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.

Key facts

MDR report key 39512
Report number 1828132-1996-00010
Event type Injury
Brand name ACCUSTICK INTRODUCER SYSTEM
Catalog number 20/703
Manufacturer MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.
Product code DYB
Device class Class II
Date received by FDA Sep 19, 1996
Report date Aug 21, 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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