MAUDE report

MAUDE report 12810: SUCTION CATHETER KIT

Malfunction · received Apr 19, 1994 · SUPERIOR HEALTHCARE GROUP, INC.

Key facts

MDR report key 12810
Report number MW1001644
Event type Malfunction
Brand name SUCTION CATHETER KIT
Catalog number 37425
Manufacturer SUPERIOR HEALTHCARE GROUP, INC.
Product code BSY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Apr 19, 1994
Report date Apr 15, 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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