MAUDE report

MAUDE report 19582: TISSUE EXPANDER

Injury · received Dec 28, 1994 · PMT CORP.

Key facts

MDR report key 19582
Report number 19582
Event type Injury
Brand name TISSUE EXPANDER
Model number 3614-12I
Catalog number 4X20CM
Manufacturer PMT CORP.
Product code LCJ
Device class Unclassified
Date received by FDA Dec 28, 1994
Report date Dec 28, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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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