MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-10-29 for AMS SPHINCTER 800 URINARY PROSTHESIS 72400160 manufactured by American Medical Systems, Inc..
[3846057]
It was reported that the pt had his artificial urinary sphincter system replaced for unknown reasons. No pt complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[11374368]
Additional information for balloon: catalog #: 72400024; serial #: (b)(4); expiration date: 01/05/2014. Additional information for pump: catalog #: 72400098; serial #: (b)(4); expiration date: 01/15/2014. 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 | 2183959-2013-01133 |
| MDR Report Key | 3445269 |
| Report Source | 01,05 |
| Date Received | 2013-10-29 |
| Date of Report | 2013-06-13 |
| Date of Event | 2013-05-10 |
| Date Mfgr Received | 2013-06-13 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2013-11-05 |
| 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 | SHARON ZURN, DIRECTOR |
| Manufacturer Street | 10700 BREN ROAD WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306347 |
| 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 SPINCTER |
| Product Code | FAG |
| Date Received | 2013-10-29 |
| Catalog Number | 72400160 |
| Device Expiration Date | 2014-01-12 |
| 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 MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-10-29 |