MAUDE report

MAUDE report 27402: ENCORE TEST STRIP

No Answer Provided · received Oct 6, 1995 · BAYER DIAGNOSTIC, CO.

Key facts

MDR report key 27402
Report number MW4000853
Event type No Answer Provided
Brand name ENCORE TEST STRIP
Manufacturer BAYER DIAGNOSTIC, CO.
Product code CFR
Device class Class II
Date received by FDA Oct 6, 1995
Report date Jul 19, 1995
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
  • None Injury reports for this brand
  • No 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:

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