MAUDE report

MAUDE report 34424: MICROCOAGULATION ANALYZER

Injury · received Jul 24, 1996 · BIODATA CORP.

Key facts

MDR report key 34424
Report number MW1009555
Event type Injury
Brand name MICROCOAGULATION ANALYZER
Model number 210
Catalog number 103210
Manufacturer BIODATA CORP.
Product code GKP
Device class Class II
Date received by FDA Jul 24, 1996
Report date Jul 16, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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
  • Yes 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