MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-18 for AMS SPHINCTER 800 URINARY PROSTHESIS 72404130 manufactured by American Medical Systems, Inc..
[2358002]
On (b)(6) 2011, the pt had and aus system implanted. It was reported that on (b)(6) 2011, the pt had the entire system explanted as the urethra was damaged during dissection which lead to cuff erosion. Add'l damage to the back wall of the corpus spongiosum was also noted. The bladder was perforated during the pressure regulating balloon placement, although it was not known at the time of the surgery. The health care provider indicated the pt would be re-implanted after the urethra healed.
Patient Sequence No: 1, Text Type: D, B5
[9468013]
Add'l catalog # 72400024, 72404127. Add'l serial # (b)(4). Should add'l info become available regarding this event, it will be reevaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00570 |
| MDR Report Key | 2346983 |
| Report Source | 05 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-25 |
| Date of Event | 2011-08-31 |
| Date Mfgr Received | 2011-10-25 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2011-11-25 |
| 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 ROAD 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 | 2011-11-18 |
| Catalog Number | 72404130 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-11-18 |