TOROSA SALINE TESTICULAR LARGE

Additional Manufacturer Narrative

THE DEVICE HAS BEEN RECEIVED AT COLOPLAST; HOWEVER THE EVALUATION IS NOT YET COMPLETE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, TOROSA BECAME DEFLATED. NO HOLES COULD BE IDENTIFIED UPON EXPLANT.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED FROM THE TM INDICATED THE DEVICE WAS FILLED ACCORDING TO THE IFU AT THE TIME OF IMPLANTED. THE PATIENT DID EXPERIENCE FLUID BUILDUP IN THE SCROTUM AROUND THE IMPLANT AREA. ABOUT HALF OF THE FLUID WAS STILL INSIDE THE IMPLANT AT THE TIME OF EXPLANT WITH NO NOTICEABLE HOLES OR DAMAGE. THE PATIENT WAS A DOUBLE TOROSA IMPLANT AT THE SAME TIME AND THE OTHER IMPLANT WAS DOING JUST FINE.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED IN FREE FORMALIN LIQUID MAKING DEVICE HANDLING AND EVALUATION IMPOSSIBLE. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. BECAUSE IDENTIFICATION NUMBERS WERE NOT PROVIDED, QUALITY WAS UNABLE TO TRACE DEVICE LOT HISTORY OF THE DEVICE, COMPLAINT HISTORY, NON-CONFORMANCE'S, AND CAPAS FOR THIS LOT NUMBER. HOWEVER, ALL DEVICES SOLD AND LABELED BY THIS CORPORATION MUST PASS MANUFACTURING, QUALITY, AND STERILITY PROCEDURES PRIOR TO RELEASE.