MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-04-22 for AMS 800 ARTIFICIAL URINARY SPHINCTER UNKNOWN manufactured by American Medical Systems.
[2027955]
Received notification on (b)(6) 2011 from american medical systems that patient eb had been in our facility on (b)(6) 2011 related to a malfunction of the ams 800 artificial urinary sphincter. The company was inquiring as to the status of the artificial urinary sphincter components. We were unaware of this event at the time it happened and the product had not been sequestered. This report is being submitted at this time related to this malfunction. On (b)(6) 2011 admission and patient was discharged same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2087344 |
| MDR Report Key | 2087344 |
| Report Source | 99 |
| Date Received | 2011-04-22 |
| Date of Report | 2011-04-21 |
| Date of Event | 2011-04-14 |
| Date Facility Aware | 2011-04-14 |
| Report Date | 2011-04-21 |
| Date Reported to FDA | 2011-04-21 |
| Date Reported to Mfgr | 2011-04-21 |
| Date Added to Maude | 2011-05-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 800 ARTIFICIAL URINARY SPHINCTER |
| Generic Name | URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2011-04-22 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MA 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-04-22 |