MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-27 for ALPHA I MENTOR 3 PART INFLATABLE PENILE PROSTHESIS UNK manufactured by Mentor Minnesota, Inc..
[354814]
A pt underwent explantation of a non-functioning mentor 3 part inflatable penile prosthesis and implantation of an alpha 1 mentor 3 part prosthesis. The pt noted that the implant worked well until patient had some trauma to their groin area and pump no longer functioned. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 524098 |
| MDR Report Key | 524098 |
| Date Received | 2004-04-27 |
| Date of Report | 2004-03-01 |
| Date of Event | 2004-02-01 |
| Date Added to Maude | 2004-05-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA I MENTOR 3 PART INFLATABLE PENILE PROSTHESIS |
| Generic Name | PENILE PROSTHESIS |
| Product Code | FWH |
| Date Received | 2004-04-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 513225 |
| Manufacturer | MENTOR MINNESOTA, INC. |
| Manufacturer Address | 1525 WEST RIVER ROAD, NORTH MINNEAPOLIS MN 55411 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-27 |