TOROSA SALINE-FILLED TESTICULAR PROSTHESIS

Additional Manufacturer Narrative

THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT COMMENT ON THE CONDITION OF THE DEVICE. 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, A TOROSA TESTICULAR IMPLANT WAS REMOVED AND REPLACED AS IT DEFLATED [LEAK]. THE CAUSE COULD NOT BE DETERMINED BY THE DOCTOR, AND THE PATIENT DID NOT EXPERIENCE ANY OTHER ISSUES RELATED TO THE DEFLATION.