MAUDE report

MAUDE report 13598: INFLATABLE BREAST IMPLANT, 250 CC

No Answer Provided · received May 26, 1994 · MCGHAN MEDICAL CORP.

Key facts

MDR report key 13598
Report number MW1002264
Event type No Answer Provided
Brand name INFLATABLE BREAST IMPLANT, 250 CC
Model number STYLE 90
Catalog number 25-90240
Manufacturer MCGHAN MEDICAL CORP.
Product code FWM
Device class Class III
Date received by FDA May 26, 1994
Report date May 23, 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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