FDA Adverse Event
Summary report: N
AMS 800 URINARY CONTROL SYSTEM
MDR report key: 811305
·
Received January 31, 2007
Report
- Report Number
- MW4004275
- Date Received
- January 31, 2007
- Date of Event
- June 1, 2003
- Report Date
- January 10, 2007
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- EYZ
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMS 800 URINARY CONTROL SYSTEM | URINARY CONTROL SYSTEM | EYZ | AMERICAN MEDICAL SYSTEMS | 800 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |