MAUDE report
MAUDE report 4608: HYDROFLEX PENILE PROSTHESIS
Malfunction · received Jul 27, 1992 · AMERICAN MEDICAL SYSTEMS
Key facts
| MDR report key | 4608 |
|---|---|
| Report number | 4608 |
| Event type | Malfunction |
| Brand name | HYDROFLEX PENILE PROSTHESIS |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Product code | FAE |
| Device class | Class II |
| Date received by FDA | Jul 27, 1992 |
| Report date | Apr 20, 1992 |
| 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
- 100–999 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: