MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-16 for AMS 700 INFLATABLE PENILE PROSTHESIS 72404263 manufactured by American Medical Systems, Inc..
[1604118]
On (b)(6)2007, an ipp device was implanted. On (b)(6)2009, pt was presented with chronic right epididymoorchitis with the penile prosthesis. The pt had normal function of the penile prosthesis which could inflate and deflate easily. There was chronic adhesions from the right testis to this area due to chronic epididymoorchitis. Procedure-right orchiectomy. No components were removed or replaced. There were no complications and pt's condition was good.
Patient Sequence No: 1, Text Type: D, B5
[8610605]
This is considered an unusual event in which an ams inflatable penile prosthesis was involved. Device worked as intended. The relationship was not established between the pt's condition and the location of the penile pump. More than six months has elapsed from the time the surgery occurred to the time that ams was notified of the surgery. It is reasonably assumed that no further info will be received or deemed necessary. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2010-00311 |
| MDR Report Key | 1764316 |
| Report Source | 05 |
| Date Received | 2010-07-16 |
| Date of Report | 2010-07-14 |
| Date of Event | 2009-11-05 |
| Date Mfgr Received | 2010-07-14 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2010-07-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAROL SCHMOCK, MDR CONTACT |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 INFLATABLE PENILE PROSTHESIS |
| Generic Name | IPP |
| Product Code | JCW |
| Date Received | 2010-07-16 |
| Model Number | 72404263 |
| Catalog Number | 72404263 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-07-16 |