MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-06-18 for UROLUME ENDOPROSTHESIS * NA manufactured by American Medical Systems, Inc..
[141397]
A urolume stent was implanted between 7 and 8 yrs ago. Patient complained of pain and tenderness over the stent, frequency, urgency and difficulty urinating. Patient had a retrograde urethrogram and cystoscopy that showed hypertrophic epithelium inside the stent and a chronic abscess cavity around the proximal end of the stent. There was extravasation of contrast media at the proximal border of the stent. In 1998, the stent was excised, plus another centimeter proximally to get rid of the chronic abscess cavity and connection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-1999-00027 |
| MDR Report Key | 228286 |
| Report Source | 05 |
| Date Received | 1999-06-18 |
| Date of Report | 1999-06-15 |
| Date of Event | 1998-12-09 |
| Date Mfgr Received | 1999-06-01 |
| Date Added to Maude | 1999-06-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROLUME ENDOPROSTHESIS |
| Generic Name | UROLUME ENDOPROSTHESIS |
| Product Code | MER |
| Date Received | 1999-06-18 |
| Model Number | * |
| Catalog Number | NA |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | Y |
| Device Sequence No | 1 |
| Device Event Key | 221369 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1999-06-18 |