MAUDE report

MAUDE report 74329: PROLENE POLYPROLENE SUTURE

Injury · received Mar 7, 1997 · ETHICON, INC.

Key facts

MDR report key 74329
Report number 2210968-1997-00046
Event type Injury
Brand name PROLENE POLYPROLENE SUTURE
Catalog number 8434H
Manufacturer ETHICON, INC.
Product code GAW
Device class Class II
Date received by FDA Mar 7, 1997
Report date Feb 5, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ 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:

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