MAUDE report
MAUDE report 6798: SURGITEK UNI-FLATE PENILE IMPLANT PROSTHESIS
Malfunction · received Jul 22, 1993 · SURGITEK
Key facts
| MDR report key | 6798 |
|---|---|
| Report number | 6798 |
| Event type | Malfunction |
| Brand name | SURGITEK UNI-FLATE PENILE IMPLANT PROSTHESIS |
| Model number | UNI-FLATE PENILE IMPLANT 1000 |
| Catalog number | 0259500 |
| Manufacturer | SURGITEK |
| Product code | FAE |
| Device class | Class II |
| Date received by FDA | Jul 22, 1993 |
| Report date | Mar 10, 1993 |
| 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
- None 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: