MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-09 for ARTIFICIAL URINARY SPHINCTER NOT REPORTED manufactured by American Medical Systems Inc.
[401381]
Urinary sphincter failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 583679 |
| MDR Report Key | 583679 |
| Date Received | 2005-03-09 |
| Date of Report | 2005-03-09 |
| Date of Event | 2005-01-28 |
| Report Date | 2005-03-09 |
| Date Reported to FDA | 2005-03-09 |
| Date Added to Maude | 2005-03-23 |
| 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 | 3 |
| 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 | ARTIFICIAL URINARY SPHINCTER |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2005-03-09 |
| Model Number | NOT REPORTED |
| Catalog Number | NOT REPORTED |
| Lot Number | NOT REPORTED |
| ID Number | * |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 573506 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS INC |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-09 |