MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-31 for AMS 800 URINARY CONTROL SYSTEM * manufactured by American Medical Systems.
[17868706]
Ams 800 urinary control system. Complainant stated in 2007, will be the third time that he has had to have this urinary control system implanted. Complaint - pamphlet received when first device was implanted in 2003, showed 75% of males implanted have experienced no problem for 5 yrs or more. Complainant had the first implant 2003, another implant in 2005, and current physician stated implant is leaking and another urinary control system will be implanted in 2007. Medwatch form sent for completion by current physician and/or complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4004275 |
| MDR Report Key | 811305 |
| Date Received | 2007-01-31 |
| Date of Report | 2007-01-10 |
| Date of Event | 2003-06-01 |
| Date Added to Maude | 2007-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 800 URINARY CONTROL SYSTEM |
| Generic Name | URINARY CONTROL SYSTEM |
| Product Code | EYZ |
| Date Received | 2007-01-31 |
| Model Number | 800 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 798791 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN RD W MINNETONKA MN 553439679 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-31 |