MAUDE report

MAUDE report 81051: GUT SURGICAL SUTURE

Injury · received Apr 4, 1997 · ETHICON, INC.

Key facts

MDR report key 81051
Report number 2210968-1997-00080
Event type Injury
Brand name GUT SURGICAL SUTURE
Catalog number 811H
Manufacturer ETHICON, INC.
Product code GAL
Device class Class II
Date received by FDA Apr 4, 1997
Report date Mar 17, 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
  • 1–9 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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