MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-09 for UROLUME ENDOPROSTHESIS AMS-72402012 manufactured by American Medical Systems.
[16365609]
Pt was exhibiting symptoms of urgency and incontinence with tissue over-growing the prostastic stent. Stent was surgically removed with tissue and sent to pathology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 249705 |
| MDR Report Key | 249705 |
| Date Received | 1999-11-09 |
| Date of Report | 1999-11-08 |
| Date of Event | 1999-11-03 |
| Date Facility Aware | 1999-11-03 |
| Report Date | 1999-11-08 |
| Date Reported to FDA | 1999-11-08 |
| Date Reported to Mfgr | 1999-11-08 |
| Date Added to Maude | 1999-11-16 |
| 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 | UROLUME ENDOPROSTHESIS |
| Generic Name | PROSTATIC STENT, 3.0 CM |
| Product Code | MER |
| Date Received | 1999-11-09 |
| Model Number | AMS-72402012 |
| Catalog Number | NI |
| Lot Number | 8C0202 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 241918 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN RD. WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-11-09 |