MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-16 for AMS INFLATABLE PENILE PROSTHESIS * manufactured by American Medical Systems Inc..
[5807318]
Patient was admitted by urologist for removal (explant) of an inflatable penile prosthesis that was not implanted at our hospital. The prosthesis eroded into the right corpora, distal urethra and bulbar urethra. It was implanted by another surgeon several years ago. Inflammation of tissue was noted during the surgery to remove the device. No prosthesis was replaced when the eroded prosthesis was removed. Surgeon placed a urethral foley catheter and suprapubic tube for drainage and repaired the urethra surgically. Patient did well post-operatively and was discharged to home the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4855820 |
| MDR Report Key | 4855820 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-04-15 |
| Report Date | 2015-06-16 |
| Date Reported to FDA | 2015-06-16 |
| Date Reported to Mfgr | 2015-06-19 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS INFLATABLE PENILE PROSTHESIS |
| Generic Name | INFLATABLE PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2015-06-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| 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 | 2015-06-16 |