MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for AMS INFLATABLE PENILE PROSTHESIS manufactured by American Medical Systems.
[29312293]
Patient Sequence No: 1, Text Type: N, H10
[29312294]
Patient had an artificial penile prosthesis implanted approximately 1 month ago at another hospital. Patient developed a superficial scrotal skin infection that drained serous fluid and eventually this resulted in opening the scrotal incision. Patient was afebrile. Surgeon recommended removal of the ipp device, which occurred during the current month. During the removal surgery, no purulence was noted involving the device. The 100 ml reservoir and cylinders were removed due to erosion and replaced. There were no complications and patient was discharged the day after surgery. Manufacturer response for inflatable penile prosthesis, ams inflatable penile prosthesis (per site reporter): manufacturer will investigate product upon receipt of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5179952 |
| MDR Report Key | 5179952 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-10-13 |
| Report Date | 2015-10-26 |
| Date Reported to FDA | 2015-10-26 |
| Date Reported to Mfgr | 2015-10-26 |
| Date Added to Maude | 2015-10-27 |
| 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 | 0 |
| 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 | 2015-10-27 |
| Returned To Mfg | 2015-10-26 |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-27 |