MAUDE report

MAUDE report 79185: BAXTER CULTURETTE SYSTEM

Injury · received Mar 26, 1997 · BECTON DICKINSON MICROBIOLOGY SYSTEM

Key facts

MDR report key 79185
Report number 79185
Event type Injury
Brand name BAXTER CULTURETTE SYSTEM
Catalog number C8852-1A
Manufacturer BECTON DICKINSON MICROBIOLOGY SYSTEM
Product code JSM
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Mar 26, 1997
Report date Mar 7, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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
  • 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