MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-28 for AMS 700 UNKNKOWN UNKNOWN manufactured by American Medical Systems, Llc.
[55792662]
Patient Sequence No: 1, Text Type: N, H10
[55792664]
The penile prosthesis that had been originally implanted in 2002 had failed. The patient was taken to the main operating room for explanting of the malfunctioning penile prosthesis and replacement with a new coloplast surgical (titan) penile prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5982794 |
| MDR Report Key | 5982794 |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-08-12 |
| Report Date | 2016-09-06 |
| Date Reported to FDA | 2016-09-06 |
| Date Reported to Mfgr | 2016-09-06 |
| Date Added to Maude | 2016-09-28 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2016-09-28 |
| Model Number | UNKNKOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | 14 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-28 |