MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-15 for ARTIFICIAL URINARY SPHINCTER manufactured by American Medical Systems, Inc..
[2495770]
On (b)(6) 2008, the pt was implanted with an aus device. On (b)(6) 2009, the cuff and pump were removed and replaced. On (b)(6) 2011, info received indicated an add'l cuff was implanted due to recurring incontinence. It was stated that the physician "used smaller cuff. " add'l info was requested. A response was received that indicated that was "erosion of tissue surrounding sphincter. "
Patient Sequence No: 1, Text Type: D, B5
[9561017]
Should add'l info become available regarding this surgery, it will be reevaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00686 |
| MDR Report Key | 2383687 |
| Report Source | 05 |
| Date Received | 2011-12-15 |
| Date of Report | 2011-09-27 |
| Date of Event | 2011-07-29 |
| Date Mfgr Received | 2011-09-27 |
| Date Added to Maude | 2011-12-22 |
| 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 ROAD 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 | ARTIFICIAL URINARY SPHINCTER |
| Generic Name | AMS 800 |
| Product Code | FAG |
| Date Received | 2011-12-15 |
| Operator | LAY USER/PATIENT |
| 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 ROAD WEST |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-15 |