The exact event date was not available, therefore the date 11/01/2023 was used as estimate, based on gfe response.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these device 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.
|
It was reported that the patient with this inflatable penile prosthesis experienced pain during intercourse.A revision surgery was performed, during which it was noted that one of the cylinders was not located in the correct place in the corpora; therefore, the cylinder was repositioned, and a new rear tip extender was implanted.There were no further patient complications reported.
|