MAUDE report

MAUDE report 48869: NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS

Injury · received Nov 7, 1996 · COCHLEAR LTD

Key facts

MDR report key 48869
Report number 1721493-1996-00005
Event type Injury
Brand name NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS
Model number CI22M
Manufacturer COCHLEAR LTD
Product code MCM
Device class Class III
Date received by FDA Nov 7, 1996
Report date Nov 7, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 100–999 Injury reports for this brand
  • 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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