There was no device available for analysis.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
|
It was reported that the patient experienced difficulty with the inflatable penile prosthesis (ipp) pump.After the implant, the patient was experiencing discomfort with cycling the device.At a later time, the patient reported being unable to access the button for deflation of the ipp as it has migrated, and the pump is too hard to press.The pump has caused pain and discomfort in the scrotum.Troubleshooting techniques were used with no resolution.The patient will follow-up with the physician.There were no additional patient complications.
|