MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-15 for AMS SPHINCTER 800 URINARY PROSTHESIS 72400161 manufactured by American Medical Systems, Inc..
[20093641]
The device was removed due to erosion.
Patient Sequence No: 1, Text Type: D, B5
[20213008]
Additional catalog #: 72400024, 72404127. Additional serial numbers: (b)(4). The device performed within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-00651 |
| MDR Report Key | 2581246 |
| Report Source | 05 |
| Date Received | 2012-05-15 |
| Date of Report | 2012-02-07 |
| Date of Event | 2011-12-17 |
| Date Mfgr Received | 2012-02-07 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2012-05-21 |
| 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 | RANDY HOYT, SENIOR MANAGER |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306277 |
| 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 | 2012-05-15 |
| Returned To Mfg | 2012-02-07 |
| Catalog Number | 72400161 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-05-15 |