MAUDE report

MAUDE report 26973: ONE TOUCH II

Malfunction · received Oct 4, 1995 · LIFESCAN, INC.

Key facts

MDR report key 26973
Report number MW4000773
Event type Malfunction
Brand name ONE TOUCH II
Manufacturer LIFESCAN, INC.
Product code CFR
Device class Class II
Date received by FDA Oct 4, 1995
Report date Sep 21, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 100–999 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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