TOROSA SALINE-FILLED TESTICULAR PROSTHESIS

Additional Manufacturer Narrative

AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED. THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT CURRENTLY HAS A MEDIUM TOROSA BUT HAS STATED THAT IT DOESN'T FIT HIS ANATOMY CORRECTLY AND EXPRESSED THAT THE LARGE SIZE ALSO ISN'T LARGE ENOUGH. THE PATIENT STATED THE PHYSICIAN ALSO NOTED THAT THERE IS NOT MUCH DIFFERENCE BETWEEN THE MEDIUM AND LARGE SIZES AND THIS PATIENT WOULD NEED A SIZE BIGGER THAN OUR LARGE.