Event was reported for two related device. This mdr will be referenced on the second report. As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint. The reported allegations could not be confirmed. The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Patient Sequence No: 1, Text Type: N, H10
It was reported that the patient indicated penis "pulling" to the right with an spectra penile prosthesis (spp). The suspected cause was scar tissue near the corpora. No surgical procedure has been performed. It was further reported that there were no device malfunctions associated with the device. No more information available at the moment. Should additional information become available, it will be provided.
Patient Sequence No: 1, Text Type: D, B5