MAUDE report

MAUDE report 67611: MONOCRYL (POLIGLECAPRONE 25) SUTURE

Injury · received Feb 6, 1997 · ETHICON INC.

Key facts

MDR report key 67611
Report number 2210968-1997-00033
Event type Injury
Brand name MONOCRYL (POLIGLECAPRONE 25) SUTURE
Catalog number Y493G
Manufacturer ETHICON INC.
Product code GAN
Device class Class II
Date received by FDA Feb 6, 1997
Report date Jan 6, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • None Death reports for this brand
  • 100–999 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:

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