MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-20 for 720066-01 manufactured by American Medical Systems, Inc..
[36423735]
Patient Sequence No: 1, Text Type: N, H10
[36423736]
Patient reports significant urinary incontinence after implantation of urinary sphincter and cuffs. These devices were removed and replaced nineteen months later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5379283 |
| MDR Report Key | 5379283 |
| Date Received | 2016-01-20 |
| Date of Report | 2015-12-30 |
| Date of Event | 2015-11-19 |
| Report Date | 2015-12-30 |
| Date Reported to FDA | 2015-12-30 |
| Date Reported to Mfgr | 2015-12-30 |
| Date Added to Maude | 2016-01-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PROSTHESIS, URETHRAL SPHINCTER |
| Product Code | FAG |
| Date Received | 2016-01-20 |
| Model Number | 720066-01 |
| Lot Number | 868990005 |
| Device Expiration Date | 2019-02-08 |
| Device Availability | N |
| Device Age | 1 DY |
| 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 | 2016-01-20 |