MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-13 for ARTIFICIAL URINARY SHINCTER 72404127 manufactured by American Medical Systems, Inc..
[2371693]
On (b)(6) 2010, the pt was originally implanted with a double cuff artificial urinary sphincter (aus). Information was received by ams that suggests the pump was removed due to "erosion through scrotal incision". The date of this event is unknown. Additional information was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[9558050]
Should additional information become available regarding this event, it will be updated in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00643 |
| MDR Report Key | 2378511 |
| Report Source | 05 |
| Date Received | 2011-12-13 |
| Date of Report | 2011-12-09 |
| Date Mfgr Received | 2011-12-09 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2011-12-19 |
| 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 | ARTIFICIAL URINARY SHINCTER |
| Generic Name | AMS 800 |
| Product Code | FAG |
| Date Received | 2011-12-13 |
| Catalog Number | 72404127 |
| 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 RD., WEST |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-13 |