MAUDE report

MAUDE report 9991: CUSTOM MONITORING KIT

No Answer Provided · received Sep 1, 1994 · ABBOTT

Key facts

MDR report key 9991
Report number 9991
Event type No Answer Provided
Brand name CUSTOM MONITORING KIT
Manufacturer ABBOTT
Date received by FDA Sep 1, 1994
Report date Sep 1, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • 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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