MAUDE report

MAUDE report 53480: 400ML RESERVOIR W/TROCAR 1/8" 10FR DRAIN

Other · received Dec 4, 1996 · MICROTEK MEDICAL, INC.

Key facts

MDR report key 53480
Report number 1416557-1996-00011
Event type Other
Brand name 400ML RESERVOIR W/TROCAR 1/8" 10FR DRAIN
Model number SU130-402D
Catalog number SU130-402D
Manufacturer MICROTEK MEDICAL, INC.
Product code GCY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Dec 4, 1996
Report date Nov 19, 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
  • None 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:

Browse all MAUDE medical device reports