FDA Adverse Event
Other
Summary report: N
AMS SPHINCTER 800 URINARY PROSTHESIS
MDR report key: 2470688
·
Received February 24, 2012
Report
- Report Number
- 2183959-2012-00235
- Event Type
- Other
- Date Received
- February 24, 2012
- Date of Event
- July 27, 2010
- Report Date
- March 16, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE REEVALUATED AND A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
ON (B)(6) 2001, AN AMS 800 URINARY PROSTHESIS WAS IMPLANTED. ON (B)(6) 2010, THE PT HAD A SURGICAL PROCEDURE. INFO PROVIDED INDICATED A CUFF WAS IMPLANTED. ADD'L INFO RECEIVED ON (B)(6) 2011, INDICATED THE PT DID NOT HAVE THE PREVIOUS CUFF REMOVED. THE PT HAD ANOTHER CUFF IMPLANTED, FOR A DOUBLE CUFF DEVICE, DUE TO URETHRAL, CUFF ATROPHY. THE PT OUTCOME WAS REPORTED TO BE "DRY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMS SPHINCTER 800 URINARY PROSTHESIS | ARTIFICIAL URINARY SPHINCTER | FAG | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| O |