FDA Adverse Event
Injury
Summary report: N
AMS SPHINCTER 800 URINARY PROSTHESIS
MDR report key: 2431179
·
Received January 25, 2012
Report
- Report Number
- 2183959-2012-00096
- Event Type
- Injury
- Date Received
- January 25, 2012
- Date of Event
- September 15, 2011
- Report Date
- September 23, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH AN AUS DEVICE ON (B)(6) 2011. ON (B)(6) 2011 PT WAS EXPERIENCING DIFFICULTY ACTIVATING AND DEACTIVATING THE DEVICE. IT WAS REPORTED THAT ON (B)(6) 2011 THE PUMP AND BALLOON WERE REMOVED AND REPLACED DUE TO "BREAK IN HIS TUBING." IT WASN'T A PUMP PROBLEM.
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. | AUS | 708970002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |