TOROSA SALINE-FILLED TESTICULAR PROSTHESIS

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION THE CUSTOMER REQUESTED TO REMOVE THE DAMAGED DEVICE. THE LEFT SCROTUM WAS SHRUNKEN; PALPATION REVEALED A HARD, DEFORMED OBJECT INSIDE THE SCROTUM. AN INCISION WAS MADE ALONG THE ANTERIOR MIDLINE OF THE LEFT SCROTUM, APPROXIMATELY 3 CM IN LENGTH. DISSECTION WAS CARRIED THROUGH THE SKIN AND MUSCLE LAYERS INTO THE LEFT TUNICA VAGINALIS CAVITY. A LARGE AMOUNT OF CLEAR YELLOW FLUID WAS OBSERVED. ONE SILICONE OBJECT, SOFT AND PLIABLE, RESEMBLING A COMPRESSED ARTIFICIAL TESTICLE, WAS REMOVED FROM THE LEFT TUNICA VAGINALIS. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A POSSIBLE LEAK THROUGH A NEEDLE PUNCTURE SITE AFTER FILLING.

Additional Manufacturer Narrative

H2: CORRECTION. THIS IS A DUPLICATE SUBMISSION DUE TO TECHNICAL DIFFICULTIES THAT OCCURRED WITH OUR PREVIOUS FOLLOW-UP SUBMISSION THE INFORMATION RECEIVED INDICATED THE DEVICE HAD A LEAKAGE THROUGH THE NEEDLE PUNCTURE SITE AFTER FILLING, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. 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.

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION THE CUSTOMER REQUESTED TO REMOVE THE DAMAGED DEVICE. THE LEFT SCROTUM WAS SHRUNKEN; PALPATION REVEALED A HARD, DEFORMED OBJECT INSIDE THE SCROTUM. AN INCISION WAS MADE ALONG THE ANTERIOR MIDLINE OF THE LEFT SCROTUM, APPROXIMATELY 3 CM IN LENGTH. DISSECTION WAS CARRIED THROUGH THE SKIN AND MUSCLE LAYERS INTO THE LEFT TUNICA VAGINALIS CAVITY. A LARGE AMOUNT OF CLEAR YELLOW FLUID WAS OBSERVED. ONE SILICONE OBJECT, SOFT AND PLIABLE, RESEMBLING A COMPRESSED ARTIFICIAL TESTICLE, WAS REMOVED FROM THE LEFT TUNICA VAGINALIS. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A POSSIBLE LEAK THROUGH A NEEDLE PUNCTURE SITE AFTER FILLING.

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.