MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-14 for AMS UROLUME ENDOPROSTHESIS AMS-7240211 * manufactured by American Medical Systems.
[17171357]
The urologist attempted to insert urolume to relieve/correct prostatic obstbuction. Urolume falied to deploy. This was attempted 2 more times. On removal, of device after last insertion, the urethra was torn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 260228 |
| MDR Report Key | 260228 |
| Date Received | 2000-01-14 |
| Date of Report | 2000-01-13 |
| Date of Event | 1999-10-25 |
| Date Facility Aware | 2000-01-13 |
| Report Date | 2000-01-14 |
| Date Added to Maude | 2000-02-01 |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS UROLUME ENDOPROSTHESIS |
| Generic Name | STENT. |
| Product Code | MER |
| Date Received | 2000-01-14 |
| Model Number | AMS-7240211 |
| Catalog Number | * |
| Lot Number | EE741 |
| ID Number | * |
| Device Expiration Date | 2001-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 252033 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 9 | 1. Hospitalization | 2000-01-14 |