MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for AMS 700 LGX MS PUMP IZ/PRECONNECTED - INFRAPUBIC 72404257 manufactured by American Medical Systems, Inc..
[119867050]
Patient with an implantable penile prosthesis was brought to surgery for explant of the device, without replacement. The right cylinder was eroded. Surgeon removed the rear extender, reservoir, right and left cylinder, and a penile kit. No pus was noted during the surgery. Cultures were obtained for suspected infection and sent to lab for examination. The patient was status post radical prostatectomy followed by placement of a penile implant for erectile dysfunction placed in (b)(6)2012 at this hospital. In 2012 the patient had salvage radiation therapy. Surgeon noted a prosthesis infection in his 2018 documentation. There were no complications post-op and the patient was discharged home in good condition. ====================== manufacturer response for implantable penile prosthesis, ams (per site reporter). ====================== ams will investigate the device when they receive it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7864238 |
| MDR Report Key | 7864238 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-08-01 |
| Report Date | 2018-08-20 |
| Date Reported to FDA | 2018-08-20 |
| Date Reported to Mfgr | 2018-09-10 |
| Date Added to Maude | 2018-09-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 700 LGX MS PUMP IZ/PRECONNECTED - INFRAPUBIC |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2018-09-11 |
| Returned To Mfg | 2018-08-21 |
| Model Number | 72404257 |
| Device Availability | R |
| Device Age | 6 YR |
| 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 | 2018-09-11 |