MAUDE report

MAUDE report 10343: 5 MM TROCAR KIT

Injury · received Nov 9, 1993 · UNITED STATES SURGICAL CORP.

Key facts

MDR report key 10343
Report number 10343
Event type Injury
Brand name 5 MM TROCAR KIT
Model number 5 MM TROCAR KIT
Catalog number 178016
Manufacturer UNITED STATES SURGICAL CORP.
Product code KDC
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Nov 9, 1993
Report date Oct 26, 1993
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
  • 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