MAUDE report

MAUDE report 23998: SUTURE CUTTING NEEDLE

Malfunction · received Jul 14, 1995 · ETHICON

Key facts

MDR report key 23998
Report number 23998
Event type Malfunction
Brand name SUTURE CUTTING NEEDLE
Model number 4-0
Catalog number 662
Manufacturer ETHICON
Product code GAB
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Jul 14, 1995
Report date May 15, 1995
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
  • None 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