MAUDE report

MAUDE report 40937: ARJO DEXTRA

Other · received Sep 30, 1996 · ARJO MANUFACTURING CO.

Key facts

MDR report key 40937
Report number 1922538-1996-00096
Event type Other
Brand name ARJO DEXTRA
Model number GBXXXX
Catalog number GB1001
Manufacturer ARJO MANUFACTURING CO.
Product code FSA
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Sep 30, 1996
Report date Sep 30, 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
  • 1–9 Death reports for this brand
  • 1–9 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:

Browse all MAUDE medical device reports