MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-11 for SPHINCTER, URINARY * manufactured by American Medical Systems.
[15538485]
A malfunction of a urinary sphincter occurred. There was a loss of fluid from the implant. The plan is for return and evaluation of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2345786 |
| MDR Report Key | 2345786 |
| Date Received | 2011-11-11 |
| Date of Event | 2011-11-27 |
| Report Date | 2011-11-11 |
| Date Reported to FDA | 2011-11-11 |
| Date Added to Maude | 2011-11-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPHINCTER, URINARY |
| Generic Name | URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2011-11-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 706637012, 699372005, 70344901 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN RD W EDEN PRAIRIE MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-11 |