MAUDE report

MAUDE report 11090: CRONIN GEL BREAST PROSTHESIS, 200 CC, PATCHLESS

Malfunction · received Jan 27, 1994 · DOW CORNING CORP.

Key facts

MDR report key 11090
Report number MW1000510
Event type Malfunction
Brand name CRONIN GEL BREAST PROSTHESIS, 200 CC, PATCHLESS
Catalog number UNKNOWN
Manufacturer DOW CORNING CORP.
Product code FTR
Device class Class III
Date received by FDA Jan 27, 1994
Report date Jan 26, 1994
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
  • 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:

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