MAUDE report

MAUDE report 57061: GOLDENBERG HAPEX TORP (MALLEABLE)

Injury · received Dec 13, 1996 · ENT DIV. SMITH & NEPHEW, INC.

Key facts

MDR report key 57061
Report number 1037007-1996-00008
Event type Injury
Brand name GOLDENBERG HAPEX TORP (MALLEABLE)
Catalog number 70145917
Manufacturer ENT DIV. SMITH & NEPHEW, INC.
Product code ETB
Device class Class II
Date received by FDA Dec 13, 1996
Report date Dec 12, 1996
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
  • 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:

Browse all MAUDE medical device reports