MAUDE report

MAUDE report 52923: DE ROYAL

Death · received Nov 26, 1996 · DE ROYAL

Key facts

MDR report key 52923
Report number 52923
Event type Death
Brand name DE ROYAL
Model number M 2038
Catalog number *
Manufacturer DE ROYAL
Product code FMQ
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Nov 26, 1996
Report date Oct 14, 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
  • None 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:

Browse all MAUDE medical device reports