MAUDE report

MAUDE report 9734: SINGLE CYLINDER PENILE PROSTHESIS

Injury · received Nov 11, 1994 · UNKNOWN

Key facts

MDR report key 9734
Report number 9734
Event type Injury
Brand name SINGLE CYLINDER PENILE PROSTHESIS
Model number UNKNOWN
Catalog number UNKNOWN
Manufacturer UNKNOWN
Product code FHW
Device class Class III
Date received by FDA Nov 11, 1994
Report date Nov 11, 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
  • 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:

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