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 devices as indicated in the instructions for use.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 following the inflatable penile prosthesis implant procedure, he developed a significant hematoma due to a severed blood vessel in the scrotum.Following surgery, the penis was left in an erect state.At the 6-week post op appointment, the physician was unable to deflate the device as the patient was too sore.The patient was seen again with the same results.The patient scheduled a follow up appointment with a different physician for evaluation.Proper deflation techniques 'were discussed with the manufacturer's representative.The patient will attempt the suggested techniques.It was suggested that the patient attempt to obtain an earlier appointment or go to er if his pain/discomfort changes.No further patient complications were reported.
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