MAUDE report

MAUDE report 66764: *

Malfunction · received Jan 31, 1997 · THE LARYNGEAL MASK CO.

Key facts

MDR report key 66764
Report number 9681900-1997-00001
Event type Malfunction
Brand name *
Manufacturer THE LARYNGEAL MASK CO.
Product code CAE
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Jan 31, 1997
Report date Jan 31, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 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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