MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for AMS UNKNOWN MODEL manufactured by American Medical Systems Inc.
[95934167]
Patient Sequence No: 1, Text Type: N, H10
[95934168]
Patient had placement of an ams inflatable penile prosthesis approximately 9 years ago that has quit working due to a tubing leak. Patient was taken to surgery for surgical explant of the malfunctioning internal penile pump (ipp) device and replacement with another ams inflatable penile prosthesis. Patient tolerated the procedure well with no complications and was discharged home. Manufacturer response: for inflatable penile prosthesis (per site reporter). Manufacturer will investigate the cause of the malfunction upon receipt of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7150565 |
| MDR Report Key | 7150565 |
| Date Received | 2017-12-28 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-12-13 |
| Report Date | 2017-12-21 |
| Date Reported to FDA | 2017-12-21 |
| Date Reported to Mfgr | 2017-12-21 |
| Date Added to Maude | 2017-12-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Brand Name | AMS UNKNOWN MODEL |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2017-12-28 |
| Device Availability | Y |
| Device Age | 9 YR |
| 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 | 2017-12-28 |