MAUDE report

MAUDE report 46107: C-SECTION PACK

Injury · received Nov 4, 1996 · ALLEGIANCE-SURGICAL GROUP

Key facts

MDR report key 46107
Report number 1419729-1996-00097
Event type Injury
Brand name C-SECTION PACK
Model number SMA30CSMHE
Catalog number SMA30CSMHE
Manufacturer ALLEGIANCE-SURGICAL GROUP
Product code KKX
Device class Class II
Date received by FDA Nov 4, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 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:

Browse all MAUDE medical device reports