There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of discomfort is a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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It was reported that, years ago, the reservoir of this inflatable penile prosthesis migrated to the scrotum, making it hard for the patient to use.It also caused discomfort.The device was explanted and replaced.No further patient complications were reported.
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