MAUDE report
MAUDE report 7569: UNIFLATE 1000 INFLATABLE PENILE IMPLANT
Malfunction · received Jan 13, 1994 · SURGITEK
Key facts
| MDR report key | 7569 |
|---|---|
| Report number | 7569 |
| Event type | Malfunction |
| Brand name | UNIFLATE 1000 INFLATABLE PENILE IMPLANT |
| Model number | UNIFLATE 1000 13X120MM SHORT |
| Catalog number | LP96621-00 |
| Manufacturer | SURGITEK |
| Product code | FAE |
| Device class | Class II |
| Date received by FDA | Jan 13, 1994 |
| Report date | Nov 22, 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
- 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: