MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-27 for SPECTRA CONCEALABLE PENILE PROSTHESIS 720054-01 manufactured by American Medical Systems, Inc..
[2001715]
On (b)(6) 2009, a spectra non-inflatable penile prosthesis was implanted. On (b)(6) 2010, the device was removed, it was indicated that the "prior prosthesis had migrated out of penis previously. " further f/u indicated that the pt complained of discomfort and there was cylinder migration. However, it was stated that there was no erosion or infection noted. The pt had a penile prosthesis reimplanted on (b)(6) 2011. No pt complications reported.
Patient Sequence No: 1, Text Type: D, B5
[9021358]
Should additional information becomes available regarding this event, it will be re-evaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00185 |
| MDR Report Key | 2114044 |
| Report Source | 05 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-18 |
| Date of Event | 2010-11-15 |
| Date Mfgr Received | 2011-05-18 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2011-06-09 |
| 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 | JON CORNELL, SR MANAGER |
| Manufacturer Street | 10700 BREN ROAD WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRA CONCEALABLE PENILE PROSTHESIS |
| Generic Name | PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2011-05-27 |
| Catalog Number | 720054-01 |
| 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 ROAD WEST MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-05-27 |