Description of Event or Problem · 0
I REQUEST AN INVESTIGATION INTO COLOPLAST WHICH MAKES MEDICAL DEVICES. IN (B)(6) 2013, UROLOGIST (B)(6) MD IMPLANTED A COLOPLAST TITAN PENILE PROSTHESIS. IT IS FAILED IN (B)(6) 2019. IT WAS REPLACED IN (B)(6) 2019 BY UROLOGIST (B)(6), MD. THE SECOND DEVICE FAILED IN OC(B)(6) 2023. SHE PLACED THE THIRD TITAN PROSTHESIS IN (B)(6) 2024. AFTER THE FIRST DEVICE BROKE, COLOPLAST UPON EVALUATION ADMITTED IT WAS DEFECTIVE, AND REIMBURSED THE COST OF THE DEVICE (BUT NOT THE SURGICAL EXPENSE). HOWEVER, AFTER THE SECOND DEVICE BROKE, DR. (B)(6) INFORMED ME COLOPLAST AGAIN FOUND THIS DEFECTIVE BUT WOULD NOT REIMBURSE THE COST OF THE DEFECTIVE PROSTHESIS. YET THEIR PAMPHLET "STRAIGHT TALK ABOUT ERECTILE DYSFUNCTION" STATES "COLOPLAST WILL REPLACE THE INFLATABLE IMPLANT OR ANY COMPONENT, FOR ANY REASON DURING THE LIFETIME OF THE PATIENT". I HAVE LOST A SIGNIFICANT AMOUNT OF INCOME FROM CLOSING MY MEDICAL PRACTICE DURING RECOVERY, AND CASH OUTLAY FOR SURGICAL COSTS. I EXPERIENCED EXCRUCIATING POSTOP PENILE AND SCROTAL PAIN AS WELL AS GREAT MENTAL DISTRESS AS A RESULT OF THESE PRODUCT FAILURES. I THEREFORE REQUEST AN INVESTIGATION OF COLOPLAST FOR FRAUD FOR NOT HONORING THEIR GUARANTEE OF REIMBURSEMENT FOR FAILED DEVICES. I FURTHER REQUEST THE FACILITY WHICH FABRICATED THESE DEFECTIVE DEVICES CEASE PRODUCTION UNTIL THE MANUFACTURING DEFECT IS IDENTIFIED AND CORRECTED. REF REPORT: MW5170696.