MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-24 for AMS CX 700 CX UNKNOWN manufactured by American Medical Systems Inc.
[4442103]
Patient was admitted with organic erectile dysfunction as a surgical patient for replacement of an inflatable penile prosthesis that had lost fluid and does not function. The original device was placed approximately four years ago at another facility. The original device was placed through a penoscrotal approach. Patient had surgery to explant the malfunctioning device and replace it using an infrapubic approach. The patient was discharged to home on post-op day 2 with no complications. Device was saved by the hospital for investigation by ams. ====================== manufacturer response for inflatable penile prosthesis, ams 18 cm cx penile prosthesis (per site reporter). ====================== ams rep was present during the removal of the malfunctioning device. Product will be released to ams for investigation of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3788169 |
| MDR Report Key | 3788169 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-04-24 |
| Date of Event | 2014-01-22 |
| Report Date | 2014-04-24 |
| Date Reported to FDA | 2014-04-24 |
| Date Reported to Mfgr | 2014-05-05 |
| Date Added to Maude | 2014-05-05 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS CX |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2014-04-24 |
| Model Number | 700 CX |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | R |
| Device Age | 4 YR |
| 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 | 2014-04-24 |