MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-04 for PROSTHESIS, PENILE 700LGX MS, PUMP W/ CYLINDERS 72404252 * manufactured by American Medical Systems.
[2676827]
The patient returned with complaints that the penile implant that was implanted approximately a year ago would get as rigid as desired. On physical exam, it was found that more pumps than expected were required and the implant would not maintain the rigidity after about two minutes. The reservoir was tested intraoperatiely and found to be functioning well. The pump was replaced. The patient was discharged from the hospital with a followup scheduled in three weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2609809 |
| MDR Report Key | 2609809 |
| Date Received | 2012-06-04 |
| Date of Report | 2012-06-04 |
| Date of Event | 2012-05-24 |
| Report Date | 2012-06-04 |
| Date Reported to FDA | 2012-06-04 |
| Date Added to Maude | 2012-06-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHESIS, PENILE 700LGX MS, PUMP W/ CYLINDERS |
| Generic Name | PENILE PROSTHESIS PUMP |
| Product Code | JCW |
| Date Received | 2012-06-04 |
| Returned To Mfg | 2012-06-04 |
| Model Number | 72404252 |
| Catalog Number | * |
| Lot Number | 690015003 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-06-04 |