MAUDE report

MAUDE report 31964: COLLECTION SWAB

Other · received Apr 11, 1996 · BARTELS DIAGNOSTICS DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 31964
Report number MW1008858
Event type Other
Brand name COLLECTION SWAB
Manufacturer BARTELS DIAGNOSTICS DIV. BAXTER HEALTHCARE CORP.
Product code KXG
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Apr 11, 1996
Report date Mar 29, 1996
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
  • None Injury reports for this brand
  • Yes 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