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 (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 the patient with this malleable device experienced pain and discomfort during sexual intercourse.In addition, the device was reported not to be performing as expected as it does not acquire rigidity.The device remains implanted, and a revision surgery has been scheduled.No additional patient complications were reported.
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