MAUDE report

MAUDE report 63787: NAMIC CUSTOM KIT

Malfunction · received Jan 9, 1997 · NAMIC USA CORP.

Key facts

MDR report key 63787
Report number 1317056-1996-00086
Event type Malfunction
Brand name NAMIC CUSTOM KIT
Catalog number 60690397
Manufacturer NAMIC USA CORP.
Product code IZQ
Device class Class II
Date received by FDA Jan 9, 1997
Report date Jan 9, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • 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:

Browse all MAUDE medical device reports