MAUDE report

MAUDE report 13661: MEDITRACE NEONATAL ECG ELECTRODE

No Answer Provided · received Jun 1, 1994 · GRAPHIC CONTROLS CORP.

Key facts

MDR report key 13661
Report number MW1002281
Event type No Answer Provided
Brand name MEDITRACE NEONATAL ECG ELECTRODE
Catalog number 4103
Manufacturer GRAPHIC CONTROLS CORP.
Product code DRX
Device class Class II
Date received by FDA Jun 1, 1994
Report date May 26, 1994
Report source Maude

At a glance

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

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