MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-26 for AMS SPHINCTER 800 URINARY PROSTHESIS AUS 720157-01 manufactured by American Medical Systems, Inc..
[2179650]
Related to mfr report # 2183959-2011-00376. On (b)(6) 2011, the pt had an aus implanted. On (b)(6) 2011, the aus was removed due to a "defect in urethra. Scrotum filled with urine and fluid. " additional information received on (b)(6) 2011 indicated that the pt presented with penile/scrotum pain and swelling. The physician performed a cystoscopy which revealed a nick in the urethra. The physician stated that apparently during the aus implant the urethra was nicked at the cuff site.
Patient Sequence No: 1, Text Type: D, B5
[9350945]
Catalog #: balloon, 72400024; pump, 720404127. Serial #: balloon, (b)(4); pump, (b)(4). Should additional information become available regarding this event, it will be re-evaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00375 |
| MDR Report Key | 2267075 |
| Report Source | 05 |
| Date Received | 2011-09-26 |
| Date of Report | 2011-08-28 |
| Date of Event | 2011-08-28 |
| Date Mfgr Received | 2011-08-28 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2011-09-29 |
| 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. MGR |
| 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 | 2011-09-26 |
| Model Number | AUS |
| Catalog Number | 720157-01 |
| 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 | 2011-09-26 |