FDA Adverse Event
Injury
Summary report: N
AMS SPHINCTER 800 URINARY PROSTHESIS
MDR report key: 2520219
·
Received April 3, 2012
Report
- Report Number
- 2183959-2012-00382
- Event Type
- Injury
- Date Received
- April 3, 2012
- Date of Event
- March 6, 2012
- Report Date
- March 6, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER 4 MONTHS THE PT EXPERIENCED URINARY RETENTION. THE PHYSICIAN "SCOPED" THE PT AND NOTED CUFF EROSION. DURING SURGERY TO REMOVE THE CUFF, THE PHYSICIAN INDICATED THE URETHRA HAS "COMPLETELY DETACHED." THE PHYSICIAN PERFORMED AN ANASTOMOSIS OF THE URETHRA AND PUT IN AN INFRAPUBIC TUBE. THE PHYSICIAN TESTED THE CUFF AFTER EXPLANTATION AND FOUND IT TO WORK FINE. THE PT MEASUREMENTS FOR THE CUFF WERE LESS THAN 3.5 CM AND THE PT WAS THIN. THE PHYSICIAN ANTICIPATES REPLACING THE CUFF; THE BALLOON AND PUMP REMAINED IMPLANTED.
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 | 72 YR | Hospitalization| R |