MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-04-03 for AMS SPHINCTER 800 URINARY PROSTHESIS 720157-01 manufactured by American Medical Systems, Inc..
[2529246]
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.
Patient Sequence No: 1, Text Type: D, B5
[9898205]
Should add'l info become available regarding this event, it will be re-evaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-00382 |
| MDR Report Key | 2520219 |
| Report Source | 05,07 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-03-06 |
| Date of Event | 2012-03-06 |
| Date Mfgr Received | 2012-03-06 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JON CORNELL, SR MANAGER |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS SPHINCTER 800 URINARY PROSTHESIS |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2012-04-03 |
| Catalog Number | 720157-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-03 |