MAUDE report
MAUDE report 9573: INFLATABLE PENILE PROSTHESIS
No Answer Provided · received Aug 18, 1993 · AMERICAN MEDICAL SYSTEM
Key facts
| MDR report key | 9573 |
|---|---|
| Report number | 9573 |
| Event type | No Answer Provided |
| Brand name | INFLATABLE PENILE PROSTHESIS |
| Model number | 700 SERIES |
| Manufacturer | AMERICAN MEDICAL SYSTEM |
| Product code | FAE |
| Device class | Class II |
| Date received by FDA | Aug 18, 1993 |
| Report date | Jul 31, 1993 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1,000+ MAUDE reports for this brand
- None Death reports for this brand
- 1,000+ Injury reports for this brand
- 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: