MAUDE report

MAUDE report 79890: SURGITEK TISSUE EXPANDER

Injury · received Mar 31, 1997 · MEDICAL ENGINEERING CORP

Key facts

MDR report key 79890
Report number 2182596-1997-00280
Event type Injury
Brand name SURGITEK TISSUE EXPANDER
Model number UNK
Manufacturer MEDICAL ENGINEERING CORP
Product code LCJ
Device class Unclassified
Date received by FDA Mar 31, 1997
Report date Mar 27, 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
  • 1–9 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