MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for 800 (TM) CUFF WITH IZ 72404130 manufactured by American Medical Systems, Inc..
[28509255]
Patient Sequence No: 1, Text Type: N, H10
[28509256]
The patient had this ams artificial sphincter inserted this past spring and it never worked. The device was explanted this fall and the cuff was noted to have a pin hole in it. Unknown cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5155822 |
| MDR Report Key | 5155822 |
| Date Received | 2015-10-16 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-21 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-16 |
| 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 | 2015-10-16 |
| Model Number | 800 (TM) CUFF WITH IZ |
| Catalog Number | 72404130 |
| Lot Number | 915573009 |
| Device Expiration Date | 2015-12-20 |
| Device Availability | Y |
| 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. Other | 2015-10-16 |