MAUDE report

MAUDE report 20541

Injury · received Nov 2, 1994 · MEDISYSTEMS CORP.

Key facts

MDR report key 20541
Report number 2243621-1994-01072
Event type Injury
Catalog number M3--9692/9793
Manufacturer MEDISYSTEMS CORP.
Product code FKJ
Device class Class II
Date received by FDA Nov 2, 1994
Report date Oct 4, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • Yes Adverse event flagged
  • No 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