MAUDE report

MAUDE report 55835: COOK INTRAOSSEOUS INFUSION NEEDLE

Injury · received Dec 17, 1996 · COOK INC.

Key facts

MDR report key 55835
Report number 1820334-1996-00050
Event type Injury
Brand name COOK INTRAOSSEOUS INFUSION NEEDLE
Catalog number C-DIN-16-4.0-T45-DKM-M
Manufacturer COOK INC.
Product code GAA
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Dec 17, 1996
Report date Nov 18, 1996
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
  • 1–9 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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