MAUDE report

MAUDE report 67255: ARROW BIPOLAR PACING CATHETER

Injury · received Feb 5, 1997 · ARROW INTERNATIONAL, INC.

Key facts

MDR report key 67255
Report number 2242445-1997-00004
Event type Injury
Brand name ARROW BIPOLAR PACING CATHETER
Catalog number UNK
Manufacturer ARROW INTERNATIONAL, INC.
Product code DYG
Device class Class II
Date received by FDA Feb 5, 1997
Report date Feb 4, 1997
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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