MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for PROSTHESIS, PENIS, INFLATABLE manufactured by American Medical Systems, Llc (boston Scientific).
[82593054]
Patient Sequence No: 1, Text Type: N, H10
[82593055]
Patient was admitted from nursing home with a penile implant exposed, without pain or tenderness. Left cylinder of the device was extruded through the urethral meatus. Surgeon noted that it appeared as if the implant was placed through a penis/scrotal incision. Surgeon explanted both cylinders. The device appeared to be a 2-piece inflatable penile prosthesis of an unknown brand placed elsewhere years ago. There was a corporal defect just inside the meatus from the eroded implant. Meatus wound was irrigated, but not closed because the patient has a suprapubic tube, which was changed during the same surgery. Penis scrotal wound was closed. Patient tolerated the procedure and there were no complications. Patient was discharged to nursing home on post-op day 2 in stable condition. Manufacturer response for inflatable penile prosthesis, (per site reporter): manufacturer will investigate the cause when the device is returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6791364 |
| MDR Report Key | 6791364 |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-08-02 |
| Report Date | 2017-08-07 |
| Date Reported to FDA | 2017-08-07 |
| Date Reported to Mfgr | 2017-08-07 |
| Date Added to Maude | 2017-08-14 |
| 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 |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2017-08-14 |
| Returned To Mfg | 2017-08-08 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, LLC (BOSTON SCIENTIFIC) |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |