MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-11 for TANDEM CUFF AMS 800 ARTIFICIAL URETHRAL SPHINCTER 4.0 manufactured by American Medical Systems, Inc..
[3371157]
The tandem cuff ams 800 artificial urethral sphincter that was inserted (b)(6) 2010 had to be replaced on (b)(6) 2012 because it was found to be exposed within the bladder itself and a nonfunctioning artificial urinary sphincter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028634 |
| MDR Report Key | 2922305 |
| Date Received | 2013-01-11 |
| Date of Report | 2013-01-11 |
| Date of Event | 2012-12-26 |
| Date Added to Maude | 2013-01-22 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TANDEM CUFF AMS 800 ARTIFICIAL URETHRAL SPHINCTER 4.0 |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2013-01-11 |
| Lot Number | 628809017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-01-11 |