MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-04 for AMS SPHINCTER 800 URINARY PROSTHESIS AUS 72400160 manufactured by American Medical Systems, Inc..
[16420234]
Should additional info become available regarding this event, it will be reevaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[16535560]
On (b)(6) 2007, an aus device was implanted. On (b)(6) 2010, the cuff component was removed and replaced due to pt complaint of incontinence. Some atrophy was noted at the time of the removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2011-00498 |
| MDR Report Key | 2328783 |
| Report Source | 05 |
| Date Received | 2011-11-04 |
| Date of Report | 2010-05-25 |
| Date of Event | 2010-05-25 |
| Date Mfgr Received | 2010-05-25 |
| Date Added to Maude | 2011-11-10 |
| 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 | AMS SPHINCTER 800 URINARY PROSTHESIS |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2011-11-04 |
| Model Number | AUS |
| Catalog Number | 72400160 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-11-04 |