MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-21 for AMS 800 manufactured by American Medical Systems.
[4110483]
Patient found to have erosion of artificial urinary sphincter (aus). Patient with a history of prostate cancer status post prostatectomy. He had a biochemical recurrence which was treated with radiation therapy because he underwent neoadjuvant therapy with lupron. He was noted to have hydronephrosis and during workup for this underwent cystoscopy and was found to have erosion of artificial urinary sphincter for which he elected to undergo explantation of the aus device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3505546 |
| MDR Report Key | 3505546 |
| Date Received | 2013-11-21 |
| Date of Report | 2013-10-20 |
| Date of Event | 2013-07-16 |
| Report Date | 2013-10-20 |
| Date Reported to FDA | 2013-11-21 |
| Date Reported to Mfgr | 2013-12-09 |
| Date Added to Maude | 2013-12-09 |
| 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 |
| 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 | AMS 800 |
| Generic Name | PROSTHESIS, URETHRAL SPHINCTER |
| Product Code | FAG |
| Date Received | 2013-11-21 |
| Model Number | 800 |
| Catalog Number | 800 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 6 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-21 |