MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-23 for SPECTRA CONCEALABLE PENILE PROSTHESIS 720054-01 manufactured by American Medical Systems, Inc..
[2442150]
On (b)(6) 2011, the pt was implanted with a spectra penile prosthesis device. On (b)(6) 2011, the entire device was removed and replaced with an inflatable penile prosthesis due to infection.
Patient Sequence No: 1, Text Type: D, B5
[9495015]
Should add'l info become available regarding this event, it will be reevaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00587 |
| MDR Report Key | 2358664 |
| Report Source | 05 |
| Date Received | 2011-11-23 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-10-31 |
| Date Mfgr Received | 2011-11-02 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2011-12-06 |
| 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 MGR |
| Manufacturer Street | 10700 BREN RD., 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 | 2011-11-23 |
| 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 RD., WEST MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-11-23 |