MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-07-30 for AMS 700 INFLATABLE PENILE PROSTHESIS IPP 72403964 72402970 manufactured by American Medical Systems, Inc..
[1624355]
A (b)(6) old male with radical/pelvic surgery was implanted with an ipp device on (b)(6) 2006. On (b)(6) 2009, pt reported his device is no longer working properly. Pt has not been scheduled for a revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[8581299]
The frequency of occurrence of the event is addressed in the device labeling. The frequency for this event is not greater than is usual. Unable to determine if the event is related to a device malfunction, device remains implanted at this time. No conclusion can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2010-00322 |
| MDR Report Key | 1781369 |
| Report Source | 00 |
| Date Received | 2010-07-30 |
| Date of Report | 2009-12-17 |
| Date of Event | 2009-12-17 |
| Date Mfgr Received | 2009-12-17 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2010-11-18 |
| 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 | CAROL SCHMOCK |
| Manufacturer Street | 10700 BREN RD WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306425 |
| 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 | 2010-07-30 |
| Model Number | IPP |
| Catalog Number | 72403964 72402970 |
| 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. Deathisabilit | 2010-07-30 |