MAUDE report

MAUDE report 75182: SURGILENE

Injury · received Mar 12, 1997 · SHERWOOD DAVIS AND GECK

Key facts

MDR report key 75182
Report number 2648188-1997-00005
Event type Injury
Brand name SURGILENE
Catalog number 9612-41
Manufacturer SHERWOOD DAVIS AND GECK
Product code GAM
Device class Class II
Date received by FDA Mar 12, 1997
Report date Feb 10, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes 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