MAUDE report

MAUDE report 47523: BACT/ALERT CULTURE BOTTLE

Injury · received Nov 6, 1996 · ORGANON TEKNIKA CORP.

Key facts

MDR report key 47523
Report number 1039284-1996-00005
Event type Injury
Brand name BACT/ALERT CULTURE BOTTLE
Catalog number 59268
Manufacturer ORGANON TEKNIKA CORP.
Product code MDB
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Nov 6, 1996
Report date Nov 6, 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
  • 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