MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-19 for AMS SPHINCTER 800 URINARY PROSTHESIS 72404130 manufactured by American Medical Systems, Inc..
[20651013]
The pt originally had an artificial urinary sphincter system with tandem cuff placement. It was reported the pt experienced recurring incontinence and had one cuff replaced. Additional info was requested, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[20906361]
Should additional info become available regarding this event, it will be re-evaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-00443 |
| MDR Report Key | 2546390 |
| Report Source | 05 |
| Date Received | 2012-04-19 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-12-19 |
| Date Mfgr Received | 2011-12-20 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2012-04-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JON CORNELL, SR. MANAGER |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS SPHINCTER 800 URINARY PROSTHESIS |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2012-04-19 |
| Catalog Number | 72404130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-19 |