MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-02 for MENTOR SALINE TESTICULAR PROSTHESIS REF 96-450-1329 * manufactured by Mentor Corporation.
[1082332]
Patient underwent implantation of testicular prosthesis. Patient had several visits to ed the following year for pain and spasms. He underwent ct scans and ultrasounds. Approximately, two years later the prosthesis ruptured and was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1337199 |
| MDR Report Key | 1337199 |
| Date Received | 2009-03-02 |
| Date of Report | 2009-03-02 |
| Date of Event | 2007-11-13 |
| Report Date | 2009-03-02 |
| Date Reported to FDA | 2009-03-02 |
| Date Added to Maude | 2009-03-10 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENTOR SALINE TESTICULAR PROSTHESIS |
| Generic Name | SALINE TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2009-03-02 |
| Model Number | REF 96-450-1329 |
| Catalog Number | * |
| Lot Number | 5716962-018 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR CORPORATION |
| Manufacturer Address | 201 MENTOR DRIVE SANTA BARBARA CA 93111 US 93111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-02 |