MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-11 for AMS 700 INFLATABLE PENILE PROSTHESIS 72403358 manufactured by American Medical Systems, Inc..
[1690625]
A (b)(6) old, male, was implanted with an ipp device on (b)(6) 2006. On (b)(6) 2009, the entire device was removed and replaced. Reason not indicated. Ams has requested additional info.
Patient Sequence No: 1, Text Type: D, B5
[8746414]
Catalog numbers 72400151, 72400152. (b)(4). Unable to confirm if the event is related to a device malfunction, device has not been returned for analysis and reason prompting this event was not provided. No conclusion can be drawn at this time. Three attempts have been made to obtain additional info and were unsuccessful. Should additional info becomes available regarding a revision surgery it will be re-evaluated and a f/u report sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2010-00329 |
| MDR Report Key | 1883355 |
| Report Source | 05 |
| Date Received | 2010-08-11 |
| Date of Report | 2010-08-17 |
| Date of Event | 2010-07-09 |
| Date Mfgr Received | 2009-08-17 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2010-10-29 |
| 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 | 2010-08-11 |
| Catalog Number | 72403358 |
| Lot Number | 363912003 |
| 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 | 2010-08-11 |