MAUDE report

MAUDE report 7472: NI

Injury · received Feb 9, 1994 · CARPENTIER-EDWARDS

Key facts

MDR report key 7472
Report number 7472
Event type Injury
Brand name NI
Model number NI
Catalog number NI
Manufacturer CARPENTIER-EDWARDS
Product code ISP
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Feb 9, 1994
Report date Sep 22, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 MAUDE reports for this product code
  • 1,000+ MAUDE reports for this brand
  • 100–999 Death reports for this brand
  • 1,000+ 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:

Browse all MAUDE medical device reports