MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-14 for AMS 700 INFLATABLE PENILE PROSTHESIS 72402984; 72402970 manufactured by American Medical Systems, Inc..
[1825140]
A (b)(6) male was implanted with an ipp device on (b)(6) 2004. On (b)(6) 2010, the entire device was removed and replaced due to pain, infection and erosion at scrotum.
Patient Sequence No: 1, Text Type: D, B5
[8883415]
Unable to confirm if the event is related to a device malfunction, device has not been returned for analysis. No conclusion can be drawn at this time. Ams has requested the return of the explanted device. Should additional information become available regarding this revision surgery it will be re-evaluated and a follow-up report will be sent. The event is captured in our labeling as a foreseeable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2010-00461 |
| MDR Report Key | 1932915 |
| Report Source | 05 |
| Date Received | 2010-12-14 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-09-28 |
| Date Mfgr Received | 2010-09-28 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2010-12-28 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 INFLATABLE PENILE PROSTHESIS |
| Generic Name | IPP |
| Product Code | JCW |
| Date Received | 2010-12-14 |
| Catalog Number | 72402984; 72402970 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2010-12-14 |