MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-23 for VIAGRA manufactured by Encore.
[935433]
I was operated on for penile implant. One week later i got an infection which the surgeon could not clear. About a month later i had the penile device removed. I have had some success in using a vacuum tube for hardness but it is too difficult to use and embarrassing. The operating doctor had me try viagra but didn't expect any results, and there was none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008397 |
| MDR Report Key | 1174083 |
| Date Received | 2008-09-23 |
| Date of Report | 2008-09-23 |
| Date of Event | 1996-08-12 |
| Date Added to Maude | 2008-09-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIAGRA |
| Generic Name | ENCORE VACUUM TUBE |
| Product Code | LKY |
| Date Received | 2008-09-23 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1206898 |
| Manufacturer | ENCORE |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-09-23 |