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 the patient, with an inflatable penile prosthesis (ipp), presented to the physician with pain and could not use the device due to this.The physician performed scans and identified that the device was crossed over and suspected to have been implanted incorrectly.The patient underwent surgical intervention to explant the device.The physician re-dilated, and a new ambicor penile prosthesis was implanted.There were no additional patient complications reported.
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