MAUDE report

MAUDE report 68627: ACCU-CHECK ADVANTAGE

Injury · received Feb 11, 1997 · BOEHRINGER MANNHEIM CORP.

Key facts

MDR report key 68627
Report number 1823260-1997-00013
Event type Injury
Brand name ACCU-CHECK ADVANTAGE
Model number 768
Catalog number 553
Manufacturer BOEHRINGER MANNHEIM CORP.
Product code CFR
Device class Class II
Date received by FDA Feb 11, 1997
Report date Jan 24, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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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