Description of Event or Problem · 0
REPORTER CALLED TO SUBMIT A REPORT ABOUT HIS ADVERSE EVENTS AFTER HE HAD A UROLIFT SYSTEM IMPLANT. HE SAID AFTER THE PROCEDURE HE WAS TOLD THAT THE IMPLANT WOULD LAST FOR 10 YEARS. ABOUT 6 MONTHS LATER, HE EXPERIENCED HEAVY BLEEDING. HE WAS BLEEDING FOR 10 DAYS. HE SAID HE WAS HAVING CYSTOSCOPY, AND THEY SAW A STAPLE IN HIS BLADDER. HE REACHED OUT TO THE MANUFACTURER AND TALKED TO A REPRESENTATIVE, AND WAS TOLD, THAT THE PROCEDURE WAS NOT DONE CORRECTLY. HE SAID HE ASKED IF THIS INCIDENT WAS REPORTED TO FDA, AND HE WAS TOLD THE DOCTOR IS NOT SUPPOSED TO SUBMIT A REPORT ON HIS BEHALF. HE WAS ALSO TOLD BY THE COMPANY REPRESENTATIVE THE FAILURE RATE IS ONLY 10 PERCENT. WHEN HE CHECKED WITH HIS DOCTOR, HE WAS TOLD THE FAILURE RATE IS 25 PERCENT. HE SAID, HAD HE KNOWN IF THE FAILURE RATE WAS THAT HIGH, HE WOULD NOT HAVE DONE IT. HE SAID THAT IS WHY HE CALLED TO SUBMIT THE REPORT HIMSELF.