SALINE TESTICULAR LARGE

Description of Event or Problem

AS REPORTED TO COLOPLAST, AN ITEM WAS DAMAGED/ BROKEN. AFTER IMPLANT, THE PATIENT HAD PAIN AND SPASMS THE FOLLOWING YEAR. APPROXIMATELY TWO YEARS LATER, THE PROSTHESIS RUPTURED AND WAS REMOVED.

Description of Event or Problem

AS REPORTED TO COLOPLAST, AN ITEM WAS DAMAGED/ BROKEN. AFTER IMPLANT, THE PATIENT HAD PAIN AND SPASMS THE FOLLOWING YEAR. APPROXIMATELY TWO YEARS LATER, THE PROSTHESIS RUPTURED AND WAS REMOVED.

Additional Manufacturer Narrative

THE RETURN OF THE DEVICE HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE IS STILL AVAILABLE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, AN ADDENDUM TO THIS REPORT WILL BE FILED. DEVICE NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING REVEALED FOUR SEPARATIONS BETWEEN THE MID LINE AND INJECTION PORT ON THE SHELL OF THE DEVICE. TESTING REVEALED THESE TO BE THE SITES OF LEAKAGE. MICROSCOPIC EXAMINATION OF THE SURFACES REVEALED BOTH SEPARATIONS WITH A CENTRAL GROOVE INDICATING THAT THE AREA WAS IN CONTACT WITH A SMALL SHARP INSTRUMENT SUCH AS A NEEDLE. BECAUSE THIS COMPONENT WAS RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, COLOPLAST CONCLUDED THAT THE OBSERVED INSTRUMENT DAMAGE ON THE TESTICULAR SHELL OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. THIS WOULD OCCUR WHEN THE SALINE IS INTRODUCED INTO THE SHELL THROUGH THE INJECTION PORT BY NEEDLE WHEN PREPPING THE DEVICE FOR IMPLANT OR WHEN PREPPING THE DEVICE FOR STERILIZATION AFTER EXPLANT. THE DEVICE WAS RETURNED STERILIZED WITH A BUTTERFLY NEEDLE INSERTED INTO THE INJECTION PORT. BECAUSE THE DEVICE WAS IMPLANTED FOR 13 MONTHS, COLOPLAST CANNOT DETERMINE THE SEQUENCE OF THE REPORTED EVENT.