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 IN VEEVA TO BE ASSOCIATED. 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, DURING PREPARATION, THERE WAS A FLUID LEAK NOTED. THE DEVICE WAS NOT INSERTED OR IMPLANTED.

Additional Manufacturer Narrative

A TESTICULAR IMPLANT WAS RECEIVED FOR EVALUATION. A SEPARATION WAS NOTED IN THE SHELL OF THE TESTICULAR IMPLANT. THIS WAS A SITE OF LEAKAGE. THE SEPARATION APPEARED TO HAVE A CENTRAL GROOVE, INDICATING CONTACT WITH SHARP INSTRUMENTATION SUCH AS A NEEDLE. BECAUSE THIS COMPONENT WAS RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, IT WAS CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATION IN THE TESTICULAR SHELL OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. THE TESTICULAR DEVICE WAS RETURNED WITH SALINE INSIDE. BASED ON THE EVALUATION AND INFORMATION RECEIVED, IT WAS CONCLUDED THAT THE SEPARATION MOST LIKELY OCCURRED INADVERTENTLY DURING THE FILLING OF THE DEVICE PRIOR TO IMPLANT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.