MAUDE report

MAUDE report 66989: STERIS 20 STERILANT CONCENTRATE

Malfunction · received Feb 5, 1997 · STERIS CORP.

Key facts

MDR report key 66989
Report number 1527821-1997-00001
Event type Malfunction
Brand name STERIS 20 STERILANT CONCENTRATE
Catalog number S2008
Manufacturer STERIS CORP.
Product code MLR
Device class Class II
Date received by FDA Feb 5, 1997
Report date Feb 5, 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
  • 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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