MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-27 for AMS 800 UNK manufactured by American Medical System.
[3043948]
Removed the old aus (artificial urinary sphincter). No fluid found in indwelling aus, may have been malfunctioning due to leak. Initially the new system appeared to be working fine but now the patient is leaking urine just as bad as before the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2850018 |
| MDR Report Key | 2850018 |
| Date Received | 2012-11-27 |
| Date of Report | 2012-11-24 |
| Date of Event | 2012-09-18 |
| Report Date | 2012-11-24 |
| Date Reported to FDA | 2012-11-27 |
| Date Added to Maude | 2012-11-29 |
| 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 | AMS 800 |
| Generic Name | PROSTHESIS, SPHINCTER |
| Product Code | FAG |
| Date Received | 2012-11-27 |
| Returned To Mfg | 2012-11-05 |
| Model Number | AMS 800 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | R |
| Device Age | 6 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEM |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-27 |