MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-18 for INFLATABLE PENILE PROSTHESIS 72404252 manufactured by American Medical Systems, Inc..
[2834673]
It was indicated that on an unk date the device was removed due to "prior infection from erosion into rectum". Additional info was requested, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[10045426]
Catalog #72404155, serial #(b)(4). Should additional info become available, it will be re-evaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-01295 |
| MDR Report Key | 2666915 |
| Report Source | 05 |
| Date Received | 2012-07-18 |
| Date of Report | 2012-06-26 |
| Date Mfgr Received | 2012-06-26 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2012-07-25 |
| 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 | RANDY HOYT, SR., MGR. |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306277 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFLATABLE PENILE PROSTHESIS |
| Generic Name | PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2012-07-18 |
| Catalog Number | 72404252 |
| 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 | MINNETONKA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-07-18 |