MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-11-19 for AMS 700 INFLATABLE PENILE PROSTHESIS 72404250 72404156 manufactured by American Medical Systems, Inc..
[16374290]
A (b)(6) year old male with peyronie's disease was implanted with an ipp device on (b)(6) 2009. On (b)(6) 2010, the pt reported his ipp pump doesn't work, but he is holding onto deflate bar while trying to squeeze the inflate bulb. Then the bulb collapses after only one squeeze and slowly refills. Gave pt correct method. On (b)(6) 2010, pt indicated he needed a revision surgery. On (b)(6) 2010, pt suggested again he will need a revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[16421473]
A revision surgery has not been determined at this time. Should additional information become available regarding a revision surgery, it will be re-evaluated and a follow-up report sent. Unable to confirm if the event is related to a device malfunction. The device still remains implanted. No conclusion can be drawn at this time. It has been requested we do not contact this pt for additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2010-00432 |
| MDR Report Key | 1913018 |
| Report Source | 00 |
| Date Received | 2010-11-19 |
| Date of Report | 2010-09-29 |
| Date of Event | 2010-09-29 |
| Date Mfgr Received | 2010-09-29 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2011-03-18 |
| 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 | JON CORNELL, SR. MANAGER |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 INFLATABLE PENILE PROSTHESIS |
| Generic Name | IPP |
| Product Code | JCW |
| Date Received | 2010-11-19 |
| Model Number | 72404250 72404156 |
| Catalog Number | 72404250 72404156 |
| 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. Deathisabilit | 2010-11-19 |