MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-25 for AMS SPHINCTER 800 URINARY PROSTHESIS AUS 72400024 manufactured by American Medical Systems, Inc..
[17098101]
The pt was implanted with an aus device on (b)(6) 2011. On (b)(6) 2011 pt was experiencing difficulty activating and deactivating the device. It was reported that on (b)(6) 2011 the pump and balloon were removed and replaced due to "break in his tubing. " it wasn't a pump problem.
Patient Sequence No: 1, Text Type: D, B5
[17352812]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-00096 |
| MDR Report Key | 2431179 |
| Report Source | 05 |
| Date Received | 2012-01-25 |
| Date of Report | 2011-09-23 |
| Date of Event | 2011-09-15 |
| Date Mfgr Received | 2011-09-23 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2012-01-31 |
| 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 | 2012-01-25 |
| Model Number | AUS |
| Catalog Number | 72400024 |
| Lot Number | 708970002 |
| 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 | 2012-01-25 |