MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-05 for AMS SPHINCTER 800 URINARY PROSTHESIS manufactured by American Medical Systems, Inc..
[2510067]
On (b)(6) 2009 an artificial urinary sphincter was implanted. On (b)(6) 2010, the patient underwent surgery. It appeared that only a deactivation package was used with no indication that any components were explanted or that additional components were implanted at the time of the surgery. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
[9564807]
Should additional information 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 | 2183959-2011-00616 |
| MDR Report Key | 2362903 |
| Report Source | 05 |
| Date Received | 2011-12-05 |
| Date of Report | 2010-06-10 |
| Date of Event | 2010-06-10 |
| Date Mfgr Received | 2010-06-10 |
| Date Added to Maude | 2011-12-09 |
| 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. MGR. |
| 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 | 2011-12-05 |
| 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 RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-05 |