MAUDE report

MAUDE report 66561: ACCU-CHEK INSTANT

Injury · received Jan 31, 1997 · BOEHRINGER MANNAHEIM CORP.

Key facts

MDR report key 66561
Report number 1823260-1997-00002
Event type Injury
Brand name ACCU-CHEK INSTANT
Model number 914 (METER)
Catalog number 913 (STRIPS)
Manufacturer BOEHRINGER MANNAHEIM CORP.
Product code CFR
Device class Class II
Date received by FDA Jan 31, 1997
Report date Jan 14, 1997
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
  • None Death reports for this brand
  • 10–99 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:

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