TOROSA SALINE-FILLED TESTICULAR PROSTHESIS

Additional Manufacturer Narrative

AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NON-CONFORMANCES AND CAPAS COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST 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, THE TOROSA WAS EXPLANTED AND REPLACED AS THE PATIENT WAS UNHAPPY WITH HOW THE IMPLANT MOVED AROUND [MIGRATED] AS THE ORIGINAL IMPLANT WAS NOT SUTURED DOWN.