MAUDE report

MAUDE report 33827: ULTRA PLUS BLOOD GLUCOSE METER

No Answer Provided · received Jun 28, 1996 · HOME DIAGNOSTICS, INC.

Key facts

MDR report key 33827
Report number MW4001382
Event type No Answer Provided
Brand name ULTRA PLUS BLOOD GLUCOSE METER
Manufacturer HOME DIAGNOSTICS, INC.
Product code CFR
Device class Class II
Date received by FDA Jun 28, 1996
Report date Jun 28, 1996
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
  • 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:

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