MAUDE report

MAUDE report 33413: EDM VENTRICULAR DRAINAGE KIT

Other · received Jun 13, 1996 · PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

Key facts

MDR report key 33413
Report number MW1009294
Event type Other
Brand name EDM VENTRICULAR DRAINAGE KIT
Catalog number 46141
Manufacturer PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
Product code HCA
Device class Class II
Date received by FDA Jun 13, 1996
Report date Jun 6, 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
  • 1–9 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