MAUDE report
MAUDE report 10261: AMS HYDROFLEX PENILE PROSTHESIS
Malfunction · received Sep 30, 1993 · AMERICAN MEDICAL SYSTEMS
Key facts
| MDR report key | 10261 |
|---|---|
| Report number | 10261 |
| Event type | Malfunction |
| Brand name | AMS HYDROFLEX PENILE PROSTHESIS |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Product code | FHW |
| Device class | Class III |
| Date received by FDA | Sep 30, 1993 |
| Report date | Sep 29, 1993 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 10–99 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 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: