MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-02-21 for AMS 700 INFLATABLE PENILE PROSTHESIS 72403964 manufactured by American Medical Systems, Inc..
[1714529]
On (b)(6) 2006, the patient had an ipp device implanted. On (b)(6) 2010, it was stated that the pump was replaced due to a malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8835270]
The pump was returned for analysis. The pump was rated unsatisfactory. It failed specifications for the inflation test.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00082 |
| MDR Report Key | 2006149 |
| Report Source | 05 |
| Date Received | 2011-02-21 |
| Date of Report | 2010-11-28 |
| Date of Event | 2010-08-10 |
| Date Mfgr Received | 2010-11-28 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2011-03-08 |
| 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., MGR |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 INFLATABLE PENILE PROSTHESIS |
| Generic Name | IPP |
| Product Code | JCW |
| Date Received | 2011-02-21 |
| Returned To Mfg | 2011-01-19 |
| Catalog Number | 72403964 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-02-21 |