MAUDE report

MAUDE report 16004: SURGICAL SIMPLEX P

Death · received Jun 22, 1994 · HOWMEDICA INTERNATIONL LTD.

Key facts

MDR report key 16004
Report number 16004
Event type Death
Brand name SURGICAL SIMPLEX P
Catalog number 6191-1-001
Manufacturer HOWMEDICA INTERNATIONL LTD.
Product code LOD
Device class Class II
Date received by FDA Jun 22, 1994
Report date Jun 20, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ 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:

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