MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for AMS INFLATABLE PENILE PROSTHESIS LVL 15 INFLATABLE PENILE PROSTHESIS 72404253 LOG 511124 manufactured by American Medical Systems Inc.
[51157043]
Patient Sequence No: 1, Text Type: N, H10
[51157044]
Patient had an inflatable penile prosthesis placed 8 months prior to this admission. It did well until approximately 2 months ago, when patient noticed increased pain in penis, had erythema of glans, and erosion at the meatus was noted. Patient was taken to surgery for removal of the eroded 3-piece ams inflatable penile prosthesis. Surgeon noted he could see the cylinder coming through the glans and had difficulty with urination. There was erosion of the cylinder through the area on the ventral surface of the coronal sulcus where he had a prior piercing. There was no erosion into the urethra. Ipp was removed surgically. Surgeon placed a malleable semi-rigid prosthesis. No post-op complications and patient was discharged to home. Information on devices explanted: penile prosthesis 700 acc log 511124 lot #915544017 model 72401850. Penile prosthesis rear 4 cm. Log 511124 model 72404324. Penscr 21 mm log 511124 model 72404253. Conceal reservoir inhbz log 511124 model 72404253.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5846256 |
| MDR Report Key | 5846256 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-05-27 |
| Report Date | 2016-07-29 |
| Date Reported to FDA | 2016-07-29 |
| Date Reported to Mfgr | 2016-07-29 |
| Date Added to Maude | 2016-08-04 |
| 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 |
| Brand Name | AMS INFLATABLE PENILE PROSTHESIS |
| Generic Name | INFLATABLE PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2016-08-04 |
| Returned To Mfg | 2016-07-29 |
| Model Number | LVL 15 INFLATABLE PENILE PROSTHESIS 72404253 |
| Catalog Number | LOG 511124 |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-08-04 |