MAUDE report
MAUDE report 78089: MARK II INFLATBALE PENILE PROSTHESIS
Injury · received Mar 25, 1997 · MENTOR UROLOGY, INC.
Key facts
| MDR report key | 78089 |
|---|---|
| Report number | 2125050-1997-00145 |
| Event type | Injury |
| Brand name | MARK II INFLATBALE PENILE PROSTHESIS |
| Manufacturer | MENTOR UROLOGY, INC. |
| Product code | FHW |
| Device class | Class III |
| Date received by FDA | Mar 25, 1997 |
| Report date | Mar 25, 1997 |
| 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
- 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: